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21:21:8.0.1.1.21.1.1.1 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES A Subpart A—General Provisions   § 868.1 Scope. FDA     [52 FR 17734, May 11, 1987, as amended at 67 FR 76681, Dec. 13, 2002; 78 FR 18233, Mar. 26, 2013] (a) This part sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, an anesthesiology device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
21:21:8.0.1.1.21.1.1.2 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES A Subpart A—General Provisions   § 868.3 Effective dates of requirement for premarket approval. FDA     [52 FR 17734, May 11, 1987] A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PM…
21:21:8.0.1.1.21.1.1.3 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES A Subpart A—General Provisions   § 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). FDA     [65 FR 2313, Jan. 14, 2000] The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chroni…
21:21:8.0.1.1.21.2.1.1 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1030 Manual algesimeter. FDA     [54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025] (a) Identification. A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
21:21:8.0.1.1.21.2.1.10 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1430 Carbon monoxide gas analyzer. FDA       (a) Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.11 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1500 Enflurane gas analyzer. FDA       (a) Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.12 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1505 Ventilatory electrical impedance tomograph. FDA     [84 FR 15098, Apr. 15, 2019] (a) Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing; (ii) Real time evaluation of local impedance variation; (iii) Plethysmogram accuracy testing; and (iv) Use life testing of reusable components. (3) Performance data must validate reprocessing instructions for any reusable components of the device. (4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Guidance for interpretation of the images generated; (ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device; (iii) A use life for any reusable components; and (iv) Instructions for reprocessing any reusable components.
21:21:8.0.1.1.21.2.1.13 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1575 Gas collection vessel. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] (a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.14 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1620 Halothane gas analyzer. FDA       (a) Identification. A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.15 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1640 Helium gas analyzer. FDA       (a) Identification. A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.16 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1670 Neon gas analyzer. FDA       (a) Identification. A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The device may use techniques such as mass spectrometry or thermal conductivity. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.17 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1690 Nitrogen gas analyzer. FDA       (a) Identification. A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.18 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1700 Nitrous oxide gas analyzer. FDA       (a) Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.19 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1720 Oxygen gas analyzer. FDA       (a) Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.2 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1040 Powered algesimeter. FDA     [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] (a) Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.20 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1730 Oxygen uptake computer. FDA       (a) Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.21 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1750 Pressure plethysmograph. FDA       (a) Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.22 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1760 Volume plethysmograph. FDA       (a) Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.23 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1780 Inspiratory airway pressure meter. FDA       (a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.24 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1800 Rhinoanemometer. FDA       (a) Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.25 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1840 Diagnostic spirometer. FDA       (a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.26 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1850 Monitoring spirometer. FDA       (a) Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.27 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1860 Peak-flow meter for spirometry. FDA       (a) Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.28 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1870 Gas volume calibrator. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] (a) Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.29 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1880 Pulmonary-function data calculator. FDA       (a) Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.3 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1075 Argon gas analyzer. FDA       (a) Identification. An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.30 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1890 Predictive pulmonary-function value calculator. FDA       (a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.31 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1900 Diagnostic pulmonary-function interpretation calculator. FDA       (a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.32 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1910 Esophageal stethoscope. FDA     [47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000] (a) Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
21:21:8.0.1.1.21.2.1.33 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1920 Esophageal stethoscope with electrical conductors. FDA       (a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.2.1.34 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1930 Stethoscope head. FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001] (a) Identification. A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological sounds. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.35 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1965 Switching valve (ploss). FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025] (a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
21:21:8.0.1.1.21.2.1.36 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1975 Water vapor analyzer. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] (a) Identification. A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.4 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1100 Arterial blood sampling kit. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] (a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.2.1.5 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer. FDA     [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004] (a) Identification. An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
21:21:8.0.1.1.21.2.1.6 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1150 Indwelling blood carbon dioxide partial pressure (P FDA     [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] (a) Identification. An indwelling blood carbon dioxide partial pressure P CO2 analyzer is a device that consists of a catheter-tip P CO2 transducer (e.g., P CO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status. (b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
21:21:8.0.1.1.21.2.1.7 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. FDA     [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] (a) Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance. (b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
21:21:8.0.1.1.21.2.1.8 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1200 Indwelling blood oxygen partial pressure (P FDA     [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] (a) Identification. An indwelling blood oxygen partial pressure (P O2 ) analyzer is a device that consists of a catheter-tip P O2 transducer (e.g., P O2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status. (b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
21:21:8.0.1.1.21.2.1.9 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES B Subpart B—Diagnostic Devices   § 868.1400 Carbon dioxide gas analyzer. FDA       (a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.3.1.1 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2025 Ultrasonic air embolism monitor. FDA       (a) Identification. An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.3.1.10 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2450 Lung water monitor. FDA     [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 FR 19834, Apr. 13, 2000] (a) Identification. A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes in thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any lung water monitor that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a lung water monitor that was in commercial distribution before May 28, 1976. Any other lung water monitor device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
21:21:8.0.1.1.21.3.1.11 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor. FDA     [54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002] (a) Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement. (b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.
21:21:8.0.1.1.21.3.1.12 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2500 Cutaneous oxygen (PcO2) monitor. FDA     [67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019] (a) Identification. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.
21:21:8.0.1.1.21.3.1.13 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2550 Pneumotachometer. FDA     [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] (a) Identification. A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.14 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2600 Airway pressure monitor. FDA       (a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.3.1.15 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2610 Gas pressure gauge. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.16 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2620 Gas pressure calibrator. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.17 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2700 Pressure regulator. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.18 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2775 Electrical peripheral nerve stimulator. FDA       (a) Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.3.1.19 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2875 Differential pressure transducer. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.2 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2300 Bourdon gauge flowmeter. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.20 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2885 Gas flow transducer. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.21 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2900 Gas pressure transducer. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] (a) Identification. A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
21:21:8.0.1.1.21.3.1.3 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2320 Uncompensated thorpe tube flowmeter. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.4 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2340 Compensated thorpe tube flowmeter. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.5 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2350 Gas calibration flowmeter. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.3.1.6 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2375 Breathing frequency monitor. FDA     [47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002] (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.3.1.7 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2377 Apnea monitor. FDA     [67 FR 46852, July 17, 2002] (a) Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”
21:21:8.0.1.1.21.3.1.8 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2380 Nitric oxide analyzer. FDA     [65 FR 14465, Mar. 3, 2000] (a) Identification. The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide. (b) Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
21:21:8.0.1.1.21.3.1.9 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES C Subpart C—Monitoring Devices   § 868.2385 Nitrogen dioxide analyzer. FDA     [65 FR 11465, Mar. 3, 2000, as amended at 84 FR 71811, Dec. 30, 2019] (a) Identification. The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide. (b) Classification. Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document.
21:21:8.0.1.1.21.5.1.1 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5090 Emergency airway needle. FDA       (a) Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.10 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5150 Anesthesia conduction needle. FDA       (a) Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.11 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5160 Gas machine for anesthesia or analgesia. FDA       (a) Gas machine for anesthesia —(1) Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. (2) Classification. Class II (performance standards). (b) Gas machine for analgesia —(1) Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide). (2) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.12 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5165 Nitric oxide administration apparatus. FDA     [65 FR 11465, Mar. 3, 2000] (a) Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system. (b) Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
21:21:8.0.1.1.21.5.1.13 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5170 Laryngotracheal topical anesthesia applicator. FDA       (a) Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.14 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5180 Rocking bed. FDA     [47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019] (a) Identification. A rocking bed is a device intended for temporary use to help patient ventilation (breathing) by repeatedly tilting the patient, thereby using the weight of the abdominal contents to move the diaphragm. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.15 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5220 Blow bottle. FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001; 90 FR 55983, Dec. 4, 2025] (a) Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
21:21:8.0.1.1.21.5.1.16 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5240 Anesthesia breathing circuit. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.17 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5250 Breathing circuit circulator. FDA       (a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.18 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5260 Breathing circuit bacterial filter. FDA       (a) Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.19 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5270 Breathing system heater. FDA       (a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.2 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5095 Retrograde intubation device. FDA     [86 FR 73678, Dec. 28, 2021] (a) Identification. A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (§ 868.5090), syringe (§ 880.5860 of this chapter), and hemostats (§ 878.4800 of this chapter). (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Wire guide tensile, flex, fracture, and corrosion testing; (ii) Catheter tensile strength testing at likely points of failure; (iii) Catheter kink radius testing; (iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids; (v) Dimensional validation; (vi) Accuracy testing of markings; and (vii) Validation of the maximum airway pressure. (2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (3) The device must be demonstrated to be biocompatible. (4) Labeling must include: (i) Instructions for use; and (ii) Package labels that clearly identify the minimum compatible size of endotracheal tube.
21:21:8.0.1.1.21.5.1.20 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5273 Positive airway pressure delivery system. FDA     [83 FR 52966, Oct. 19, 2018] (a) Identification. A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Waveform testing must simulate breathing conditions and evaluate pressure and airflow response over a range and combination of high and low breath rates and tidal volumes. (ii) Use life testing must demonstrate adequate device performance over the labeled use life of the device. (iii) Device integrity testing must demonstrate that the device can withstand typical forces expected during use. (iv) Carbon dioxide rebreathing testing must be performed. (v) System flow rate, maximum expiratory pressure, inhalation pressure, and intra-mask static pressure testing must be performed. (vi) Air bolus testing must demonstrate that the device can withstand worst-case scenario air pressures. (vii) Maximum limited pressure testing of the flow generator in single fault condition must be performed. (viii) Maximum output temperature testing of delivered gas, if humidified, must be performed. (3) Performance data must validate reprocessing instructions for any reusable components of the device. (4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Therapy pressure range; (ii) Use life and replacement schedule for a…
21:21:8.0.1.1.21.5.1.21 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5280 Breathing tube support. FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001] (a) Identification. A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.22 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5300 Carbon dioxide absorbent. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.23 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5310 Carbon dioxide absorber. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.24 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5320 Reservoir bag. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.25 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5330 Breathing gas mixer. FDA       (a) Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.26 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5340 Nasal oxygen cannula. FDA     [47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001] (a) Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.27 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5350 Nasal oxygen catheter. FDA     [47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001] (a) Identification. A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.28 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5365 Posture chair for cardiac or pulmonary treatment. FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, 2001] (a) Identification. A posture chair for cardiac or pulmonary treatment is a device intended to assist in the rehabilitation and mobilization of patients with chronic heart or lung disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.29 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5375 Heat and moisture condenser (artificial nose). FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.3 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5100 Nasopharyngeal airway. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] (a) Identification. A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.30 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5400 Electroanesthesia apparatus. FDA     [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any electroanesthesia apparatus that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an electroanesthesia apparatus that was in commercial distribution before May 28, 1976. Any other electroanesthesia apparatus shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
21:21:8.0.1.1.21.5.1.31 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5420 Ether hook. FDA     [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001;90 FR 55983, Dec. 4, 2025 ] (a) Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
21:21:8.0.1.1.21.5.1.32 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5430 Gas-scavenging apparatus. FDA       (a) Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.33 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5440 Portable oxygen generator. FDA       (a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve). (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.34 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5450 Respiratory gas humidifier. FDA       (a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.35 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5454 High flow humidified oxygen delivery device. FDA     [83 FR 54007, Oct. 26, 2018] (a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following: (i) Alarm testing must be performed; (ii) Continuous use thermal stability testing must be performed; (iii) Humidity output testing must be performed; and (iv) Blender performance testing must evaluate fraction of inspired oxygen ( Fi O 2 ) blending accuracy. (3) Performance data must validate cleaning instructions for any reusable components of the device. (4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include: (i) A description of available Fi O 2 ranges for different flowrates and inlet gas pressures; (ii) Instructions for applicable flowrates for all intended populations; (iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry; (iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and (v) A description of all alarms and their functions.
21:21:8.0.1.1.21.5.1.36 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5460 Therapeutic humidifier for home use. FDA     [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.37 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5470 Hyperbaric chamber. FDA       (a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650). (b) Classification. Class II (performance standards).
21:21:8.0.1.1.21.5.1.38 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5480 Isocapnic ventilation device. FDA     [86 FR 68397, Dec. 2, 2021] (a) Identification. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (§ 868.5320), oxygen cannulas (§ 868.5340), masks (§ 868.5550), valves (§ 868.5870), resuscitation bags (§ 868.5915), and/or tubing (§ 868.5925). (b) Classification. Class II (special controls). The special controls for this device are: (1) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics: (i) Gas concentration accuracy testing for the range of intended concentrations; (ii) Airway pressure delivery accuracy testing; (iii) Supplemental O 2 flowrate accuracy testing; (iv) Alarm testing; and (v) Use life testing. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Labeling must include the following: (i) Instructions for use; (ii) A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and (iii) Use life specification.
21:21:8.0.1.1.21.5.1.39 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5530 Flexible laryngoscope. FDA     [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.4 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5105 External negative pressure airway aid. FDA     [82 FR 60867, Dec. 26, 2017] (a) Identification. An external negative pressure airway aid is a prescription device that applies negative pressure to a patient's neck to aid in providing a patent airway during procedures requiring anesthesia. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must document any adverse events observed during clinical use, including impaired blood flow, and demonstrate that the device performs as intended under anticipated conditions. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated patient positions, does not fail during use, and does not lose negative pressure capability. The following testing should be performed: (i) Ability of the device to maintain a seal during various patient positions; (ii) Device leakage testing to demonstrate the device maintains vacuum; (iii) Drop testing to ensure the device does not incur functional damage after dropping the device; and (iv) Functional testing after high and low storage temperature. (3) All patient contacting components must be demonstrated to be biocompatible. (4) Labeling must include: (i) A summary of clinical testing results, including any adverse events and evidence that effectiveness has been achieved. (ii) Technical specifications of the device, including collar sizes, maximum duration of use, operating temperature, and storage temperature range. (iii) Technical specifications of the vacuum source, including maximum vacuum level and operational vacuum level. (iv) Instructions for use that includes how to place the device, determination of size, verification of suction, reference to training materials, and information on troubleshooting the device if it does not attach properly. (v) A warning to screen patients for carotid artery disease due to the probable risk of the device to dislodge arterial plaques in the carotid artery. (vi) A warning to exclude patients with anatomical abnormalities. (vii) A warning n…
21:21:8.0.1.1.21.5.1.40 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5540 Rigid laryngoscope. FDA     [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9
21:21:8.0.1.1.21.5.1.41 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5550 Anesthetic gas mask. FDA     [47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.42 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5560 Gas mask head strap. FDA     [47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001] (a) Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.43 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5570 Nonrebreathing mask. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.44 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5580 Oxygen mask. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
21:21:8.0.1.1.21.5.1.45 21 Food and Drugs I H 868 PART 868—ANESTHESIOLOGY DEVICES F Subpart F—Therapeutic Devices   § 868.5590 Scavenging mask. FDA     [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway and to remove excess and exhaled gas. It is usually used during dentistry. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

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