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FDA product codes

The device classification tree, in product code order.

FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.

Data as of , the FDA export date. FDA product classification database

Review panels

6,880 codes
FDA review panels and the number of ingested product codes in each
Review panelPanel codeProduct codes
AnesthesiologyAN262
CardiovascularCV437
Clinical ChemistryCH527
Clinical ToxicologyTX338
DentalDE352
Ear, Nose, ThroatEN269
Gastroenterology, UrologyGU614
General HospitalHO394
General, Plastic SurgerySU562
HematologyHE281
ImmunologyIM278
Medical GeneticsMG7
MicrobiologyMI554
NeurologyNE291
Obstetrics/GynecologyOB269
OphthalmicOP345
OrthopedicOR349
PathologyPA325
Physical MedicinePM210
RadiologyRA216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 1 of 71
FDA product codes, page 1 of 71
CodeDevice nameClassRegulationClearancesRecalls
BRTRestraint, Patient, ConductiveClass I21 CFR 880.676000
BRWProtector, DentalClass I21 CFR 868.582030
BRXStool, AnesthesiaClass I21 CFR 868.670011
BRYCabinet, Table And Tray, AnesthesiaClass I21 CFR 868.6100599
BRZSet, Blood TransfusionClass II21 CFR 880.54403024
BSAWarmer, Blood, Electromagnetic RadiationClass III21 CFR 864.920500
BSBWarmer, Blood, Non-Electromagnetic RadiationClass II21 CFR 864.9205142
BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-IndwellingClass III00
BSEAnalyzer, Gas, Helium, Gaseous-PhaseClass II21 CFR 868.164030
BSFAbsorber, Carbon-DioxideClass I21 CFR 868.531086
BSIAlgesimeter, PoweredClass II21 CFR 868.104000
BSJMask, Gas, AnestheticClass I21 CFR 868.5550511
BSKCuff, Tracheal Tube, InflatableClass II21 CFR 868.5750404
BSNFilter, Conduction, AnestheticClass II21 CFR 868.513091
BSOCatheter, Conduction, AnestheticClass II21 CFR 868.512075119
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Class II21 CFR 868.515015217
BSRStylet, Tracheal TubeClass I21 CFR 868.57903216
BSSTube, NasogastricClass II21 CFR 876.5980135
BSTCurette, Biopsy, Bronchoscope (Non-Rigid)Class II21 CFR 874.468000
BSYCatheters, Suction, TracheobronchialClass I21 CFR 868.681011689
BSZGas-Machine, AnesthesiaClass II21 CFR 868.5160189177
BTAPump, Portable, Aspiration (Manual Or Powered)Class II21 CFR 878.478015921
BTBHook, EtherClass I21 CFR 868.542000
BTCBag, ReservoirClass I21 CFR 868.5320197
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)Class II21 CFR 874.468062
BTICompressor, Air, PortableClass II21 CFR 868.6250745
BTKStrap, Head, Gas MaskClass I21 CFR 868.556060
BTLVentilator, Emergency, Powered (Resuscitator)Class II21 CFR 868.592510029
BTMVentilator, Emergency, Manual (Resuscitator)Class II21 CFR 868.591520997
BTOTube, Tracheostomy (W/Wo Connector)Class II21 CFR 868.580012973
BTPDropper, EtherClass I21 CFR 868.542010
BTQAirway, NasopharyngealClass I21 CFR 868.5100192
BTRTube, Tracheal (W/Wo Connector)Class II21 CFR 868.5730242227
BTSTube, Bronchial (W/Wo Connector)Class II21 CFR 868.5720611
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Class II21 CFR 868.545022270
BTXBoard, Arm (With Cover), SterileClass I21 CFR 878.3910130
BTYCalculator, Predicted Values, Pulmonary FunctionClass II21 CFR 868.1890644
BWAUnit, Electrosurgical And Coagulation, With AccessoriesClass II21 CFR 878.440030
BWBForceps, Tube IntroductionClass I21 CFR 868.578061
BWCNeedle, Emergency AirwayClass II21 CFR 868.5090142
BWFSpirometer, Therapeutic (Incentive)Class II21 CFR 868.56901081
BWHForceps, Biopsy, Bronchoscope (Non-Rigid)Class II21 CFR 874.468060
BWJLocator, Acupuncture PointClass II21 CFR 880.558030
BWKStimulator, Electro-AcupunctureUnclassified230
BWLApparatus, ElectronanesthesiaClass III21 CFR 868.540000
BWNTable And Attachments, Operating-RoomClass I21 CFR 878.49502074
BWPShoe And Shoe Cover, ConductiveClass I21 CFR 878.404030
BXAAnalyzer, Gas, Water Vapor, Gaseous-PhaseClass I21 CFR 868.197520
BXBExerciser, PoweredClass I21 CFR 890.53801606
BXHGauge, Gas Pressure, Cylinder/PipelineClass I21 CFR 868.261041
BXJClip, NoseClass I21 CFR 868.622540
BXKGas, Calibration (Specified Concentration)Class I21 CFR 868.6400320
BXLAlgesimeter, ManualClass I21 CFR 868.103010
BXMStimulator, Nerve, Ac-PoweredClass II21 CFR 868.277540
BXNStimulator, Nerve, Battery-PoweredClass II21 CFR 868.2775635
BXOTransducer, Gas PressureClass I21 CFR 868.290020
BXPTransducer, Gas FlowClass I21 CFR 868.288570
BXQRhinoanemometer (Measurement Of Nasal Decongestion)Class II21 CFR 868.1800120
BXRMeter, Airway Pressure (Inspiratory Force)Class II21 CFR 868.178060
BXWCalibrator, Volume, GasClass I21 CFR 868.187060
BXXCalibrator, Pressure, GasClass I21 CFR 868.2620100
BXYFlowmeter, Calibration, GasClass I21 CFR 868.235070
BYDCondenser, Heat And Moisture (Artificial Nose)Class I21 CFR 868.53757315
BYEAttachment, Breathing, Positive End Expiratory PressureClass II21 CFR 868.59658010
BYFMask, Oxygen, Low Concentration, VenturiClass I21 CFR 868.5600193
BYGMask, OxygenClass I21 CFR 868.55805541
BYHDrain, Tee (Water Trap)Class I21 CFR 868.5995222
BYIPercussor, Powered-ElectricClass II21 CFR 868.5665583
BYJUnit, Liquid-Oxygen, PortableClass II21 CFR 868.5655556
BYKTent, Oxygen, Electrically PoweredClass II21 CFR 868.571030
BYLTent, OxygenClass I21 CFR 868.5700111
BYMTube, Thorpe, UncompensatedClass I21 CFR 868.232010
BYNChair, Posture, For Cardiac And Pulmonary TreatmentClass I21 CFR 868.536510
BYOBottle, BlowClass I21 CFR 868.522040
BYPMouthpiece, BreathingClass I21 CFR 868.5620250
BYRTransducer, Gas Pressure, DifferentialClass I21 CFR 868.287530
BYSOxygenator, Long Term Support Greater Than 6 HoursClass II21 CFR 870.410032
BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)Class II21 CFR 868.5935210
BYWDevice, RebreathingClass I21 CFR 868.567521
BYXTubing, Pressure And AccessoriesClass I21 CFR 868.5860621
BYYTube, Aspirating, Flexible, ConnectingClass II21 CFR 880.6740246
BYZTrap, Sterile SpecimenClass II21 CFR 880.674091
BZAConnector, Airway (Extension)Class I21 CFR 868.58109438
BZBCatheter, Nasal, OxygenClass I21 CFR 868.535081
BZCCalculator, Pulmonary Function DataClass II21 CFR 868.1880905
BZDVentilator, Non-Continuous (Respirator)Class II21 CFR 868.590546283
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerClass II21 CFR 868.5270467
BZGSpirometer, DiagnosticClass II21 CFR 868.18402281
BZHMeter, Peak Flow, SpirometryClass II21 CFR 868.1860810
BZKSpirometer, Monitoring (W/Wo Alarm)Class II21 CFR 868.1850623
BZLComputer, Oxygen-UptakeClass II21 CFR 868.1730330
BZMCalculator, Pulmonary Function Interpretor (Diagnostic)Class II21 CFR 868.1900260
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Class I21 CFR 868.617582
BZOSet, Tubing And Support, Ventilator (W Harness)Class I21 CFR 868.59758823
BZQMonitor, Breathing FrequencyClass II21 CFR 868.23751763
BZRMixer, Breathing Gases, Anesthesia InhalationClass II21 CFR 868.5330553
BZSStethoscope HeadClass I21 CFR 868.193030
BZTStethoscope, Esophageal, With Electrical ConductorsClass II21 CFR 868.1920464
BZWStethoscope, EsophagealClass I21 CFR 868.1910130
CACApparatus, AutotransfusionClass II21 CFR 868.583019589