FDA’s List of Potentially High-risk Medical Devices

CLASSIFIED DEVICES (with classification regulation number followed by classification name):

• 862.1345 glucose test system

• 862.2140 centrifugal chemistry analyzer for clinical use

• 862.2150 continuous flow sequential multiple chemistry analyzer for clinical use

• 862.2160 discrete photometric chemistry analyzer for clinical use

• 862.2170 microchemistry analyzer for clinical use

• 868.1150 indwelling blood carbon dioxide partial pressure (PCO₂) analyzer

• 868.1200 indwelling blood oxygen partial pressure (Po₂) analyzer

• 868.1730 oxygen-uptake computer

• 868.2375 breathing frequency monitor

• 868.2450 lung water monitor

• 868.5160 gas machine for anesthesia or analgesia

• 868.5330 breathing gas mixer

• 868.5400 electroanesthesia apparatus

• 868.5440 portable oxygen generator

• 868.5470 hyperbaric chamber

• 868.5610 membrane lung (for long-term pulmonary support)

• 868.5830 autotransfusion apparatus

• 868.5880 anesthetic vaporizer

• 868.5895 continuous ventilator

• 868.5925 powered emergency ventilator

• 868.5935 external negative pressure ventilator

• 868.5955 intermittent mandatory ventilation attachment

• 870.1025 arrhythmia detector and alarm

• 870.1750 external programmable pacemaker pulse generator

• 870.3535 intra-aortic balloon and control system

• 870.3545 ventricular bypass (assist) device

• 870.3600 external pacemaker pulse generator

• 870.3610 implantable pacemaker pulse-generator

• 870.3700 pacemaker programmers

• 870.4220 cardiopulmonary bypass heart-lung machine console

• 870.4320 cardiopulmonary bypass pulsatile flow generator

• 870.4330 cardiopulmonary bypass on-line blood gas monitor

• 870.4360 nonroller-type cardiopulmonary bypass blood pump

• 870.4370 roller-type cardiopulmonary bypass blood pump

• 870.4380 cardiopulmonary bypass pump speed control

• 870.5225 external counter-pulsating device

• 870.5300 dc-defibrillator low energy (including paddles)

• 876.5270 implanted electrical urinary continence device

• 876.5630 peritoneal dialysis system and accessories

• 876.5820 hemodialysis systems and accessories

• 876.5860 high permeability hemodialysis system

• 876.5870 sorbent hemoperfusion system

• 876.5880 isolated kidney perfusion and transport system and accessories

• 880.5130 infant radiant warmer

• 880.5400 neonatal incubator

• 880.5410 neonatal transport incubator

• 880.5725 infusion pump

• 882.5820 implanted cerebellar stimulator

• 882.5830 implanted diaphragmatic/phrenic nerve stimulator

• 882.5840 implanted intracerebral/subcortical stimulator for pain relief

• 882.5850 implanted spinal cord stimulator for bladder evacuation

• 882.5860 implanted neuromuscular stimulator

• 882.5870 implanted peripheral nerve stimulator for pain relief

• 882.5880 implanted spinal cord stimulator for pain relief

• 884.1700 hysteroscopic insufflator

• 884.1730 laparoscopic insufflator

• 884.2660 fetal ultrasonic monitor and accessories

The following device classifications include radiation treatment planning systems that are accessories to these device types:

• 892.5050 medical charged-particle radiation therapy system

• 892.5300 medical neutron radiation therapy system

• 892.5700 remote-controlled radionuclide-applicator system

• 892.5750 radionuclide radiation therapy system

• 892.5900 X-ray radiation therapy system

Post-medical device amendments Class III devices, and devices not yet classified:

• Ventilator, high-frequency

• Cardioconverter, implantable

• Defibrillator, automatic implantable cardioverter

• Defibrillator, implantable, dual chamber

• Pulse-generator, dual chamber, implantable

• Pulse-generator, program module

• Pulse-generator, single chamber, sensor driven, implantable

• Pulse-generator, single chamber

• System, pacing, temporary, acute, internal atrial defibrillation

• Automated blood cell and plasma separator for therapeutic purposes

• Lipoprotein, low density, removal

• Separator for therapeutic purposes, membrane automated blood cell/plasma

• Pump, drug administration, closed loop

• Pump, infusion, implanted, programmable

• Kit, test, alpha-fetoprotein for neural tube defects

• Stimulator, cortical, implanted for pain

• Stimulator, electrical, implanted, for parkinsonian tremor

• Stimulator, sacral nerve, implanted

• Stimulator, spinal-cord, totally implanted for pain relief

• Stimulator, subcortical, implanted for epilepsy

• Device, thermal ablation, endometrial