Title 21

PART 868

Part 868 - Anesthesiology Devices

PART 868 - ANESTHESIOLOGY DEVICES 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.

21:8.0.1.1.21.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.21.1.1.1SECTION 868.1
   868.1 Scope.
21:8.0.1.1.21.1.1.2SECTION 868.3
   868.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.21.1.1.3SECTION 868.9
   868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.21.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.21.2.1.1SECTION 868.1030
   868.1030 Manual algesimeter.
21:8.0.1.1.21.2.1.2SECTION 868.1040
   868.1040 Powered algesimeter.
21:8.0.1.1.21.2.1.3SECTION 868.1075
   868.1075 Argon gas analyzer.
21:8.0.1.1.21.2.1.4SECTION 868.1100
   868.1100 Arterial blood sampling kit.
21:8.0.1.1.21.2.1.5SECTION 868.1120
   868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
21:8.0.1.1.21.2.1.6SECTION 868.1150
   868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
21:8.0.1.1.21.2.1.7SECTION 868.1170
   868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
21:8.0.1.1.21.2.1.8SECTION 868.1200
   868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
21:8.0.1.1.21.2.1.9SECTION 868.1400
   868.1400 Carbon dioxide gas analyzer.
21:8.0.1.1.21.2.1.10SECTION 868.1430
   868.1430 Carbon monoxide gas analyzer.
21:8.0.1.1.21.2.1.11SECTION 868.1500
   868.1500 Enflurane gas analyzer.
21:8.0.1.1.21.2.1.12SECTION 868.1505
   868.1505 Ventilatory electrical impedance tomograph.
21:8.0.1.1.21.2.1.13SECTION 868.1575
   868.1575 Gas collection vessel.
21:8.0.1.1.21.2.1.14SECTION 868.1620
   868.1620 Halothane gas analyzer.
21:8.0.1.1.21.2.1.15SECTION 868.1640
   868.1640 Helium gas analyzer.
21:8.0.1.1.21.2.1.16SECTION 868.1670
   868.1670 Neon gas analyzer.
21:8.0.1.1.21.2.1.17SECTION 868.1690
   868.1690 Nitrogen gas analyzer.
21:8.0.1.1.21.2.1.18SECTION 868.1700
   868.1700 Nitrous oxide gas analyzer.
21:8.0.1.1.21.2.1.19SECTION 868.1720
   868.1720 Oxygen gas analyzer.
21:8.0.1.1.21.2.1.20SECTION 868.1730
   868.1730 Oxygen uptake computer.
21:8.0.1.1.21.2.1.21SECTION 868.1750
   868.1750 Pressure plethysmograph.
21:8.0.1.1.21.2.1.22SECTION 868.1760
   868.1760 Volume plethysmograph.
21:8.0.1.1.21.2.1.23SECTION 868.1780
   868.1780 Inspiratory airway pressure meter.
21:8.0.1.1.21.2.1.24SECTION 868.1800
   868.1800 Rhinoanemometer.
21:8.0.1.1.21.2.1.25SECTION 868.1840
   868.1840 Diagnostic spirometer.
21:8.0.1.1.21.2.1.26SECTION 868.1850
   868.1850 Monitoring spirometer.
21:8.0.1.1.21.2.1.27SECTION 868.1860
   868.1860 Peak-flow meter for spirometry.
21:8.0.1.1.21.2.1.28SECTION 868.1870
   868.1870 Gas volume calibrator.
21:8.0.1.1.21.2.1.29SECTION 868.1880
   868.1880 Pulmonary-function data calculator.
21:8.0.1.1.21.2.1.30SECTION 868.1890
   868.1890 Predictive pulmonary-function value calculator.
21:8.0.1.1.21.2.1.31SECTION 868.1900
   868.1900 Diagnostic pulmonary-function interpretation calculator.
21:8.0.1.1.21.2.1.32SECTION 868.1910
   868.1910 Esophageal stethoscope.
21:8.0.1.1.21.2.1.33SECTION 868.1920
   868.1920 Esophageal stethoscope with electrical conductors.
21:8.0.1.1.21.2.1.34SECTION 868.1930
   868.1930 Stethoscope head.
21:8.0.1.1.21.2.1.35SECTION 868.1965
   868.1965 Switching valve (ploss).
21:8.0.1.1.21.2.1.36SECTION 868.1975
   868.1975 Water vapor analyzer.
21:8.0.1.1.21.3SUBPART C
Subpart C - Monitoring Devices
21:8.0.1.1.21.3.1.1SECTION 868.2025
   868.2025 Ultrasonic air embolism monitor.
21:8.0.1.1.21.3.1.2SECTION 868.2300
   868.2300 Bourdon gauge flowmeter.
21:8.0.1.1.21.3.1.3SECTION 868.2320
   868.2320 Uncompensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.4SECTION 868.2340
   868.2340 Compensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.5SECTION 868.2350
   868.2350 Gas calibration flowmeter.
21:8.0.1.1.21.3.1.6SECTION 868.2375
   868.2375 Breathing frequency monitor.
21:8.0.1.1.21.3.1.7SECTION 868.2377
   868.2377 Apnea monitor.
21:8.0.1.1.21.3.1.8SECTION 868.2380
   868.2380 Nitric oxide analyzer.
21:8.0.1.1.21.3.1.9SECTION 868.2385
   868.2385 Nitrogen dioxide analyzer.
21:8.0.1.1.21.3.1.10SECTION 868.2450
   868.2450 Lung water monitor.
21:8.0.1.1.21.3.1.11SECTION 868.2480
   868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
21:8.0.1.1.21.3.1.12SECTION 868.2500
   868.2500 Cutaneous oxygen (PcO2) monitor.
21:8.0.1.1.21.3.1.13SECTION 868.2550
   868.2550 Pneumotachometer.
21:8.0.1.1.21.3.1.14SECTION 868.2600
   868.2600 Airway pressure monitor.
21:8.0.1.1.21.3.1.15SECTION 868.2610
   868.2610 Gas pressure gauge.
21:8.0.1.1.21.3.1.16SECTION 868.2620
   868.2620 Gas pressure calibrator.
21:8.0.1.1.21.3.1.17SECTION 868.2700
   868.2700 Pressure regulator.
21:8.0.1.1.21.3.1.18SECTION 868.2775
   868.2775 Electrical peripheral nerve stimulator.
21:8.0.1.1.21.3.1.19SECTION 868.2875
   868.2875 Differential pressure transducer.
21:8.0.1.1.21.3.1.20SECTION 868.2885
   868.2885 Gas flow transducer.
21:8.0.1.1.21.3.1.21SECTION 868.2900
   868.2900 Gas pressure transducer.
21:8.0.1.1.21.4SUBPART D
Subparts D-E [Reserved]
21:8.0.1.1.21.5SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.21.5.1.1SECTION 868.5090
   868.5090 Emergency airway needle.
21:8.0.1.1.21.5.1.2SECTION 868.5100
   868.5100 Nasopharyngeal airway.
21:8.0.1.1.21.5.1.3SECTION 868.5105
   868.5105 External negative pressure airway aid.
21:8.0.1.1.21.5.1.4SECTION 868.5110
   868.5110 Oropharyngeal airway.
21:8.0.1.1.21.5.1.5SECTION 868.5115
   868.5115 Device to relieve acute upper airway obstruction.
21:8.0.1.1.21.5.1.6SECTION 868.5120
   868.5120 Anesthesia conduction catheter.
21:8.0.1.1.21.5.1.7SECTION 868.5130
   868.5130 Anesthesia conduction filter.
21:8.0.1.1.21.5.1.8SECTION 868.5140
   868.5140 Anesthesia conduction kit.
21:8.0.1.1.21.5.1.9SECTION 868.5150
   868.5150 Anesthesia conduction needle.
21:8.0.1.1.21.5.1.10SECTION 868.5160
   868.5160 Gas machine for anesthesia or analgesia.
21:8.0.1.1.21.5.1.11SECTION 868.5165
   868.5165 Nitric oxide administration apparatus.
21:8.0.1.1.21.5.1.12SECTION 868.5170
   868.5170 Laryngotracheal topical anesthesia applicator.
21:8.0.1.1.21.5.1.13SECTION 868.5180
   868.5180 Rocking bed.
21:8.0.1.1.21.5.1.14SECTION 868.5220
   868.5220 Blow bottle.
21:8.0.1.1.21.5.1.15SECTION 868.5240
   868.5240 Anesthesia breathing circuit.
21:8.0.1.1.21.5.1.16SECTION 868.5250
   868.5250 Breathing circuit circulator.
21:8.0.1.1.21.5.1.17SECTION 868.5260
   868.5260 Breathing circuit bacterial filter.
21:8.0.1.1.21.5.1.18SECTION 868.5270
   868.5270 Breathing system heater.
21:8.0.1.1.21.5.1.19SECTION 868.5273
   868.5273 Positive airway pressure delivery system.
21:8.0.1.1.21.5.1.20SECTION 868.5280
   868.5280 Breathing tube support.
21:8.0.1.1.21.5.1.21SECTION 868.5300
   868.5300 Carbon dioxide absorbent.
21:8.0.1.1.21.5.1.22SECTION 868.5310
   868.5310 Carbon dioxide absorber.
21:8.0.1.1.21.5.1.23SECTION 868.5320
   868.5320 Reservoir bag.
21:8.0.1.1.21.5.1.24SECTION 868.5330
   868.5330 Breathing gas mixer.
21:8.0.1.1.21.5.1.25SECTION 868.5340
   868.5340 Nasal oxygen cannula.
21:8.0.1.1.21.5.1.26SECTION 868.5350
   868.5350 Nasal oxygen catheter.
21:8.0.1.1.21.5.1.27SECTION 868.5365
   868.5365 Posture chair for cardiac or pulmonary treatment.
21:8.0.1.1.21.5.1.28SECTION 868.5375
   868.5375 Heat and moisture condenser (artificial nose).
21:8.0.1.1.21.5.1.29SECTION 868.5400
   868.5400 Electroanesthesia apparatus.
21:8.0.1.1.21.5.1.30SECTION 868.5420
   868.5420 Ether hook.
21:8.0.1.1.21.5.1.31SECTION 868.5430
   868.5430 Gas-scavenging apparatus.
21:8.0.1.1.21.5.1.32SECTION 868.5440
   868.5440 Portable oxygen generator.
21:8.0.1.1.21.5.1.33SECTION 868.5450
   868.5450 Respiratory gas humidifier.
21:8.0.1.1.21.5.1.34SECTION 868.5454
   868.5454 High flow humidified oxygen delivery device.
21:8.0.1.1.21.5.1.35SECTION 868.5460
   868.5460 Therapeutic humidifier for home use.
21:8.0.1.1.21.5.1.36SECTION 868.5470
   868.5470 Hyperbaric chamber.
21:8.0.1.1.21.5.1.37SECTION 868.5530
   868.5530 Flexible laryngoscope.
21:8.0.1.1.21.5.1.38SECTION 868.5540
   868.5540 Rigid laryngoscope.
21:8.0.1.1.21.5.1.39SECTION 868.5550
   868.5550 Anesthetic gas mask.
21:8.0.1.1.21.5.1.40SECTION 868.5560
   868.5560 Gas mask head strap.
21:8.0.1.1.21.5.1.41SECTION 868.5570
   868.5570 Nonrebreathing mask.
21:8.0.1.1.21.5.1.42SECTION 868.5580
   868.5580 Oxygen mask.
21:8.0.1.1.21.5.1.43SECTION 868.5590
   868.5590 Scavenging mask.
21:8.0.1.1.21.5.1.44SECTION 868.5600
   868.5600 Venturi mask.
21:8.0.1.1.21.5.1.45SECTION 868.5620
   868.5620 Breathing mouthpiece.
21:8.0.1.1.21.5.1.46SECTION 868.5630
   868.5630 Nebulizer.
21:8.0.1.1.21.5.1.47SECTION 868.5640
   868.5640 Medicinal nonventilatory nebulizer (atomizer).
21:8.0.1.1.21.5.1.48SECTION 868.5650
   868.5650 Esophageal obturator.
21:8.0.1.1.21.5.1.49SECTION 868.5655
   868.5655 Portable liquid oxygen unit.
21:8.0.1.1.21.5.1.50SECTION 868.5665
   868.5665 Powered percussor.
21:8.0.1.1.21.5.1.51SECTION 868.5675
   868.5675 Rebreathing device.
21:8.0.1.1.21.5.1.52SECTION 868.5690
   868.5690 Incentive spirometer.
21:8.0.1.1.21.5.1.53SECTION 868.5700
   868.5700 Nonpowered oxygen tent.
21:8.0.1.1.21.5.1.54SECTION 868.5710
   868.5710 Electrically powered oxygen tent.
21:8.0.1.1.21.5.1.55SECTION 868.5720
   868.5720 Bronchial tube.
21:8.0.1.1.21.5.1.56SECTION 868.5730
   868.5730 Tracheal tube.
21:8.0.1.1.21.5.1.57SECTION 868.5740
   868.5740 Tracheal/bronchial differential ventilation tube.
21:8.0.1.1.21.5.1.58SECTION 868.5750
   868.5750 Inflatable tracheal tube cuff.
21:8.0.1.1.21.5.1.59SECTION 868.5760
   868.5760 Cuff spreader.
21:8.0.1.1.21.5.1.60SECTION 868.5770
   868.5770 Tracheal tube fixation device.
21:8.0.1.1.21.5.1.61SECTION 868.5780
   868.5780 Tube introduction forceps.
21:8.0.1.1.21.5.1.62SECTION 868.5790
   868.5790 Tracheal tube stylet.
21:8.0.1.1.21.5.1.63SECTION 868.5795
   868.5795 Tracheal tube cleaning brush.
21:8.0.1.1.21.5.1.64SECTION 868.5800
   868.5800 Tracheostomy tube and tube cuff.
21:8.0.1.1.21.5.1.65SECTION 868.5810
   868.5810 Airway connector.
21:8.0.1.1.21.5.1.66SECTION 868.5820
   868.5820 Dental protector.
21:8.0.1.1.21.5.1.67SECTION 868.5830
   868.5830 Autotransfusion apparatus.
21:8.0.1.1.21.5.1.68SECTION 868.5860
   868.5860 Pressure tubing and accessories.
21:8.0.1.1.21.5.1.69SECTION 868.5870
   868.5870 Nonrebreathing valve.
21:8.0.1.1.21.5.1.70SECTION 868.5880
   868.5880 Anesthetic vaporizer.
21:8.0.1.1.21.5.1.71SECTION 868.5895
   868.5895 Continuous ventilator.
21:8.0.1.1.21.5.1.72SECTION 868.5905
   868.5905 Noncontinuous ventilator (IPPB).
21:8.0.1.1.21.5.1.73SECTION 868.5915
   868.5915 Manual emergency ventilator.
21:8.0.1.1.21.5.1.74SECTION 868.5925
   868.5925 Powered emergency ventilator.
21:8.0.1.1.21.5.1.75SECTION 868.5935
   868.5935 External negative pressure ventilator.
21:8.0.1.1.21.5.1.76SECTION 868.5955
   868.5955 Intermittent mandatory ventilation attachment.
21:8.0.1.1.21.5.1.77SECTION 868.5965
   868.5965 Positive end expiratory pressure breathing attachment.
21:8.0.1.1.21.5.1.78SECTION 868.5975
   868.5975 Ventilator tubing.
21:8.0.1.1.21.5.1.79SECTION 868.5995
   868.5995 Tee drain (water trap).
21:8.0.1.1.21.6SUBPART G
Subpart G - Miscellaneous
21:8.0.1.1.21.6.1.1SECTION 868.6100
   868.6100 Anesthetic cabinet, table, or tray.
21:8.0.1.1.21.6.1.2SECTION 868.6175
   868.6175 Cardiopulmonary emergency cart.
21:8.0.1.1.21.6.1.3SECTION 868.6225
   868.6225 Nose clip.
21:8.0.1.1.21.6.1.4SECTION 868.6250
   868.6250 Portable air compressor.
21:8.0.1.1.21.6.1.5SECTION 868.6400
   868.6400 Calibration gas.
21:8.0.1.1.21.6.1.6SECTION 868.6700
   868.6700 Anesthesia stool.
21:8.0.1.1.21.6.1.7SECTION 868.6810
   868.6810 Tracheobronchial suction catheter.
21:8.0.1.1.21.6.1.8SECTION 868.6820
   868.6820 Patient position support.
21:8.0.1.1.21.6.1.9SECTION 868.6885
   868.6885 Medical gas yoke assembly.