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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 26 of 71
FDA product codes, page 26 of 71
CodeDevice nameClassRegulationClearancesRecalls
IPSCaneClass I21 CFR 890.307594
IPTOrthosis, ThoracicClass I21 CFR 890.349050
IPWOrthosis, Sacroiliac, SoftClass I21 CFR 890.349010
IPXOrthosis, Rib Fracture, SoftClass I21 CFR 890.349030
IPYOrthosis, Lumbo-SacralClass I21 CFR 890.3490111
IQASystem, Environmental Control, PoweredClass II21 CFR 890.37252417
IQBBelt, WheelchairClass I21 CFR 890.392020
IQCWheelchair, Special GradeClass II21 CFR 890.3880240
IQEOrthosis, LumbarClass I21 CFR 890.349040
IQFOrthosis, Cervical-Thoracic, RigidClass I21 CFR 890.349070
IQGAdaptor, Holder, SyringeClass I21 CFR 890.505030
IQIOrthosis, Limb BraceClass I21 CFR 890.34755217
IQJSplint, ClavicleClass I21 CFR 890.349040
IQKOrthosis, CervicalClass I21 CFR 890.3490276
IQMSplint, Temporary TrainingClass I21 CFR 890.302530
IQODevice, Prosthesis AlignmentClass I21 CFR 890.302502
IQPRotator, TransverseClass I21 CFR 890.302510
IQQJoint, Shoulder, External Limb ComponentClass I21 CFR 890.342000
IQWHook, External Limb Component, PoweredClass I21 CFR 890.342000
IQXHook, External Limb Component, MechanicalClass I21 CFR 890.342010
IQZHand, External Limb Component, PoweredClass I21 CFR 890.342002
IRAHand, External Limb Component, MechanicalClass I21 CFR 890.342020
IRDJoint, Elbow, External Limb Component, MechanicalClass I21 CFR 890.342000
IREJoint, Elbow, External Limb Component, PoweredClass I21 CFR 890.342020
IRNDevice, Warning, Overload, External Limb, PoweredClass II21 CFR 890.5575110
IROVibrator, TherapeuticClass I21 CFR 890.5975652
IRPMassager, Powered Inflatable TubeClass II21 CFR 890.56501565
IRQUnit, Heating, PoweredClass I21 CFR 890.595071
IRRBars, Parallel, PoweredClass I21 CFR 890.538010
IRSHead Halter, TractionClass I21 CFR 890.592510
IRTPad, Heating, PoweredClass II21 CFR 890.57404224
ISAMassager, Therapeutic, ElectricClass I21 CFR 890.566010010
ISBStimulator, Muscle, DiagnosticClass II21 CFR 890.185050
ISDExerciser, MeasuringClass II21 CFR 890.5360612
ISHComponent, External, Limb, Ankle/FootClass I21 CFR 890.3420413
ISLJoint, Hip, External Limb ComponentClass I21 CFR 890.342001
ISMPylon, Post SurgicalClass I21 CFR 890.302501
ISNCableClass I21 CFR 890.342000
ISPValve, ProsthesisClass I21 CFR 890.342011
ISRBand Or Belt, Pelvic SupportClass I21 CFR 890.302510
ISSProsthesis, Thigh Socket, External ComponentClass I21 CFR 890.342010
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalClass II21 CFR 890.3500110
ISYJoint, Knee, External Limb ComponentClass I21 CFR 890.3420117
ISZUnit, Wrist, External Limb Component, MechanicalClass I21 CFR 890.342000
ITCStirrup, External Brace ComponentClass I21 CFR 890.341000
ITGBandage, CastClass I21 CFR 890.3025373
ITHEquipment, Traction, PoweredClass II21 CFR 890.5900715
ITIWheelchair, PoweredClass II21 CFR 890.386059071
ITJWalker, MechanicalClass I21 CFR 890.38251427
ITMCage, KneeClass I21 CFR 890.347550
ITNSplint, Denis BrownClass I21 CFR 890.367530
ITOTwister, Brace SettingClass I21 CFR 890.341010
ITQJoint, Knee, External BraceClass I21 CFR 890.34751512
ITSJoint, Hip, External BraceClass I21 CFR 890.347510
ITWJoint, Ankle, External BraceClass I21 CFR 890.347513
ITXTransducer, Ultrasonic, DiagnosticClass II21 CFR 892.1570415147
ITYAssembly, Tube Housing, X-Ray, DiagnosticClass I21 CFR 892.1760404
ITZAssembly, Tube Housing, X-Ray, TherapeuticClass II21 CFR 892.593000
IWASource, Wire, Iridium, RadioactiveClass II21 CFR 892.573080
IWBSystem, Radiation Therapy, RadionuclideClass II21 CFR 892.57504829
IWDDevice, Beam Limiting, Teletherapy, RadionuclideClass II21 CFR 892.575010
IWEMonitor, Patient Position, Light-BeamClass I21 CFR 892.5780288
IWFNeedle, Isotope, Gold, Titanium, PlatinumClass II21 CFR 892.573001
IWGSeed, Isotope, Gold, Titanium, PlatinumClass II21 CFR 892.573030
IWHSource, Teletherapy, RadionuclideClass I21 CFR 892.574000
IWISource, Isotope, Sealed, Gold, Titanium, PlatinumClass II21 CFR 892.573060
IWJSystem, Applicator, Radionuclide, ManualClass I21 CFR 892.56503611
IWKCyclotron, MedicalClass II21 CFR 892.505000
IWLSystem, Radiation Therapy, Neutron, MedicalClass II21 CFR 892.530040
IWMSynchrotron, MedicalClass II21 CFR 892.505010
IWNCassette, Measurement, Ardran-CrooksClass I21 CFR 892.194010
IWOApron, ProtectiveClass I21 CFR 892.6500113
IWPRadiographic Protective GloveClass I21 CFR 892.650050
IWQCurtain, Protective, RadiographicClass I21 CFR 892.650030
IWRHolder, Syringe, LeadClass I21 CFR 892.650040
IWSShield, Eye, RadiologicalClass I21 CFR 892.650060
IWTShield, GonadalClass I21 CFR 892.650020
IWWShield, VialClass I21 CFR 892.650010
IWXBarrier, Control Panel, X-Ray, MovableClass I21 CFR 892.650031
IWYHolder, Head, RadiographicClass I21 CFR 892.1920101
IWZFilm, RadiographicClass I21 CFR 892.18403413
IXACassette, Radiographic FilmClass II21 CFR 892.1850511
IXCIlluminator, Radiographic-FilmClass I21 CFR 892.1890180
IXDSource, Calibration, Sealed, NuclearClass I21 CFR 892.140020
IXFTest-Pattern, RadiographicClass I21 CFR 892.194050
IXGPhantom, Anthropomorphic, RadiographicClass I21 CFR 892.195040
IXHCamera, Focal Spot, RadiographicClass I21 CFR 892.194020
IXIBlock, Beam-Shaping, Radiation TherapyClass II21 CFR 892.5710516
IXJGrid, RadiographicClass I21 CFR 892.1910151
IXKSystem, Imaging, X-Ray, ElectrostaticClass II21 CFR 892.1630140
IXLDevice, Spot-FilmClass II21 CFR 892.1670133
IXOSynchronizer, Ecg / Respirator, RadiographicClass I21 CFR 892.197040
IXQTable, Radiographic, Stationary TopClass II21 CFR 892.1980277
IXRTable, Radiographic, TiltingClass II21 CFR 892.19807726
IXWProcessor, Radiographic-Film, AutomaticClass II21 CFR 892.1900831
IXXProcessor, Cine FilmClass II21 CFR 892.190060
IXYHolder, Radiographic Cassette, Wall-MountedClass I21 CFR 892.1880215
IYBTube Mount, X-Ray, DiagnosticClass I21 CFR 892.17704013
IYCGenerator, Orthovoltage, Therapeutic X-RayClass II21 CFR 892.590000
IYDGenerator, Low Voltage, Therapeutic X-RayClass II21 CFR 892.590010