Part 868 — Anesthesiology Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.
Sections
- § 868.1 Scope.
- § 868.3 Effective dates of requirement for premarket approval.
- § 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- § 868.1030 Manual algesimeter.
- § 868.1040 Powered algesimeter.
- § 868.1075 Argon gas analyzer.
- § 868.1100 Arterial blood sampling kit.
- § 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
- § 868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
- § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
- § 868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
- § 868.1400 Carbon dioxide gas analyzer.
- § 868.1430 Carbon monoxide gas analyzer.
- § 868.1500 Enflurane gas analyzer.
- § 868.1505 Ventilatory electrical impedance tomograph.
- § 868.1575 Gas collection vessel.
- § 868.1620 Halothane gas analyzer.
- § 868.1640 Helium gas analyzer.
- § 868.1670 Neon gas analyzer.
- § 868.1690 Nitrogen gas analyzer.
- § 868.1700 Nitrous oxide gas analyzer.
- § 868.1720 Oxygen gas analyzer.
- § 868.1730 Oxygen uptake computer.
- § 868.1750 Pressure plethysmograph.
- § 868.1760 Volume plethysmograph.
- § 868.1780 Inspiratory airway pressure meter.
- § 868.1800 Rhinoanemometer.
- § 868.1840 Diagnostic spirometer.
- § 868.1850 Monitoring spirometer.
- § 868.1860 Peak-flow meter for spirometry.
- § 868.1870 Gas volume calibrator.
- § 868.1880 Pulmonary-function data calculator.
- § 868.1890 Predictive pulmonary-function value calculator.
- § 868.1900 Diagnostic pulmonary-function interpretation calculator.
- § 868.1910 Esophageal stethoscope.
- § 868.1920 Esophageal stethoscope with electrical conductors.
- § 868.1930 Stethoscope head.
- § 868.1965 Switching valve (ploss).
- § 868.1975 Water vapor analyzer.
- § 868.1980 Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.
- § 868.2025 Ultrasonic air embolism monitor.
- § 868.2200 Adjunctive pain measurement device for anesthesiology.
- § 868.2250 Monitor for opioid induced impairment of oxygenation.
- § 868.2300 Bourdon gauge flowmeter.
- § 868.2320 Uncompensated thorpe tube flowmeter.
- § 868.2340 Compensated thorpe tube flowmeter.
- § 868.2350 Gas calibration flowmeter.
- § 868.2375 Breathing frequency monitor.
- § 868.2376 Device for sleep apnea testing based on mandibular movement.
- § 868.2377 Apnea monitor.
- § 868.2380 Nitric oxide analyzer.
- § 868.2385 Nitrogen dioxide analyzer.
- § 868.2450 Lung water monitor.
- § 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
- § 868.2500 Cutaneous oxygen (PcO2) monitor.
- § 868.2550 Pneumotachometer.
- § 868.2600 Airway pressure monitor.
- § 868.2610 Gas pressure gauge.
- § 868.2620 Gas pressure calibrator.
- § 868.2700 Pressure regulator.
- § 868.2775 Electrical peripheral nerve stimulator.
- § 868.2875 Differential pressure transducer.
- § 868.2885 Gas flow transducer.
- § 868.2900 Gas pressure transducer.
- § 868.5090 Emergency airway needle.
- § 868.5095 Retrograde intubation device.
- § 868.5100 Nasopharyngeal airway.
- § 868.5105 External negative pressure airway aid.
- § 868.5110 Oropharyngeal airway.
- § 868.5115 Device to relieve acute upper airway obstruction.
- § 868.5120 Anesthesia conduction catheter.
- § 868.5130 Anesthesia conduction filter.
- § 868.5140 Anesthesia conduction kit.
- § 868.5150 Anesthesia conduction needle.
- § 868.5160 Gas machine for anesthesia or analgesia.
- § 868.5165 Nitric oxide administration apparatus.
- § 868.5170 Laryngotracheal topical anesthesia applicator.
- § 868.5180 Rocking bed.
- § 868.5220 Blow bottle.
- § 868.5240 Anesthesia breathing circuit.
- § 868.5250 Breathing circuit circulator.
- § 868.5260 Breathing circuit bacterial filter.
- § 868.5270 Breathing system heater.
- § 868.5273 Positive airway pressure delivery system.
- § 868.5280 Breathing tube support.
- § 868.5300 Carbon dioxide absorbent.
- § 868.5310 Carbon dioxide absorber.
- § 868.5320 Reservoir bag.
- § 868.5330 Breathing gas mixer.
- § 868.5340 Nasal oxygen cannula.
- § 868.5350 Nasal oxygen catheter.
- § 868.5365 Posture chair for cardiac or pulmonary treatment.
- § 868.5375 Heat and moisture condenser (artificial nose).
- § 868.5400 Electroanesthesia apparatus.
- § 868.5420 Ether hook.
- § 868.5430 Gas-scavenging apparatus.
- § 868.5440 Portable oxygen generator.
- § 868.5450 Respiratory gas humidifier.
- § 868.5454 High flow humidified oxygen delivery device.
- § 868.5460 Therapeutic humidifier for home use.
- § 868.5470 Hyperbaric chamber.
- § 868.5480 Isocapnic ventilation device.
- § 868.5530 Flexible laryngoscope.
- § 868.5540 Rigid laryngoscope.
- § 868.5550 Anesthetic gas mask.
- § 868.5560 Gas mask head strap.
- § 868.5570 Nonrebreathing mask.
- § 868.5580 Oxygen mask.
- § 868.5590 Scavenging mask.
- § 868.5600 Venturi mask.
- § 868.5620 Breathing mouthpiece.
- § 868.5630 Nebulizer.
- § 868.5640 Medicinal nonventilatory nebulizer (atomizer).
- § 868.5650 Esophageal obturator.
- § 868.5655 Portable liquid oxygen unit.
- § 868.5665 Powered percussor.
- § 868.5675 Rebreathing device.
- § 868.5690 Incentive spirometer.
- § 868.5700 Nonpowered oxygen tent.
- § 868.5710 Electrically powered oxygen tent.
- § 868.5720 Bronchial tube.
- § 868.5730 Tracheal tube.
- § 868.5740 Tracheal/bronchial differential ventilation tube.
- § 868.5750 Inflatable tracheal tube cuff.
- § 868.5760 Cuff spreader.
- § 868.5770 Tracheal tube fixation device.
- § 868.5780 Tube introduction forceps.
- § 868.5790 Tracheal tube stylet.
- § 868.5795 Tracheal tube cleaning brush.
- § 868.5800 Tracheostomy tube and tube cuff.
- § 868.5810 Airway connector.
- § 868.5820 Dental protector.
- § 868.5830 Autotransfusion apparatus.
- § 868.5860 Pressure tubing and accessories.
- § 868.5870 Nonrebreathing valve.
- § 868.5880 Anesthetic vaporizer.
- § 868.5895 Continuous ventilator.
- § 868.5905 Noncontinuous ventilator (IPPB).
- § 868.5915 Manual emergency ventilator.
- § 868.5925 Powered emergency ventilator.
- § 868.5935 External negative pressure ventilator.
- § 868.5955 Intermittent mandatory ventilation attachment.
- § 868.5965 Positive end expiratory pressure breathing attachment.
- § 868.5975 Ventilator tubing.
- § 868.5995 Tee drain (water trap).
- § 868.6100 Anesthetic cabinet, table, or tray.
- § 868.6175 Cardiopulmonary emergency cart.
- § 868.6225 Nose clip.
- § 868.6250 Portable air compressor.
- § 868.6400 Calibration gas.
- § 868.6700 Anesthesia stool.
- § 868.6810 Tracheobronchial suction catheter.
- § 868.6820 Patient position support.
- § 868.6885 Medical gas yoke assembly.