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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 25 of 71
FDA product codes, page 25 of 71
CodeDevice nameClassRegulationClearancesRecalls
IFSSolution, HellyClass I21 CFR 864.401000
IFTGlutaraldehydeClass I21 CFR 864.401010
IFYGelatin-FormalinClass I21 CFR 864.401000
IFZGelatin For Specimen AdhesionClass I21 CFR 864.401010
IGBSolution, Formalin-Sodium AcetateClass I21 CFR 864.401010
IGCFormalin-SalineClass I21 CFR 864.401020
IGDSolution, Formol CalciumClass I21 CFR 864.401000
IGESolution, Formalin Ammonium BromideClass I21 CFR 864.401020
IGFSolution, Formalin-Alcohol-Acetic AcidClass I21 CFR 864.401010
IGGFormaldehyde (Formalin, Formol)Class I21 CFR 864.401071
IGKSolution, Clarke'SClass I21 CFR 864.401000
IGMSolution, Carnoy'SClass I21 CFR 864.401030
IGNFluid, Bouin'SClass I21 CFR 864.401020
IHJBlender, SputumClass I21 CFR 864.301000
IJZOil, ClearingClass I21 CFR 864.401010
IKDCable, ElectrodeClass II21 CFR 890.1175611
IKETransducer, Miniature PressureClass I21 CFR 890.1615150
IKKSystem, Isokinetic Testing And EvaluationClass II21 CFR 890.1925614
IKNElectromyograph, DiagnosticClass II21 CFR 890.1375751
IKOHammer, Reflex, PoweredClass II21 CFR 890.145010
IKPChronaximeterClass II21 CFR 890.122500
IKTElectrode, Needle, Diagnostic ElectromyographClass II21 CFR 890.1385432
IKWUtensil, HomemakingClass I21 CFR 890.5050120
IKXAid, TransferClass I21 CFR 890.50501820
IKYMattress, Flotation Therapy, Non-PoweredClass I21 CFR 880.5150811
IKZBed, Patient Rotation, PoweredClass II21 CFR 890.52251712
ILCUtensil, EatingClass I21 CFR 890.5050320
ILDAdaptor, DressingClass I21 CFR 890.5050140
ILESling, Arm, Overhead SupportedClass I21 CFR 890.347530
ILGStocking, ElasticClass I21 CFR 890.347583
ILHSplint, Hand, And ComponentsClass I21 CFR 890.3475361
ILISling, ArmClass I21 CFR 890.3640215
ILJBath, Hydro-MassageClass II21 CFR 890.51007310
ILKTransport, Patient, PoweredClass II21 CFR 890.5150367
ILMBath, Sitz, PoweredClass II21 CFR 890.510020
ILOPack, Hot Or Cold, Water CirculatingClass II21 CFR 890.57209322
ILPSystem, Communication, Non-PoweredClass I21 CFR 890.3700210
ILQSystem, Communication, PoweredClass II21 CFR 890.37103819
ILSAdaptor, HygieneClass I21 CFR 890.5050314
ILTAdaptor, RecreationalClass I21 CFR 890.505070
ILWAdaptor, GroomingClass I21 CFR 890.505070
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatClass II21 CFR 890.5290151
ILYLamp, Infrared, Therapeutic HeatingClass II21 CFR 890.550022920
ILZAccessories, TractionClass I21 CFR 890.5925150
IMAPack, Heat, MoistClass I21 CFR 890.573089
IMBCabinet, Moist SteamClass II21 CFR 890.525055
IMCBath, ParaffinClass II21 CFR 890.5110120
IMDPack, Hot Or Cold, DisposableClass I21 CFR 890.57108226
IMEPack, Hot Or Cold, ReusableClass I21 CFR 890.57002712
IMFUnit, ChillingClass I21 CFR 890.594021
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatClass II21 CFR 890.5860552
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatClass II21 CFR 890.5300893
IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep HeatClass II21 CFR 890.5290451
IMKWheelchair, Stair ClimbingClass II21 CFR 890.389034
IMLArmrest, WheelchairClass I21 CFR 890.392000
IMMFootrest, WheelchairClass I21 CFR 890.392020
IMNClimber, Curb, WheelchairClass I21 CFR 890.392000
IMOHandrim, WheelchairClass I21 CFR 890.392000
IMPCushion, WheelchairClass I21 CFR 890.392021
IMQAttachment, Narrowing, WheelchairClass I21 CFR 890.392000
IMRDevice, Anti-Tip, WheelchairClass I21 CFR 890.392000
IMSSupport, Head And Trunk, WheelchairClass I21 CFR 890.391001
IMWBrake, Extension, WheelchairClass I21 CFR 890.392000
IMXBoard, Lap, WheelchairClass I21 CFR 890.391020
IMYArmboard, WheelchairClass I21 CFR 890.391000
IMZHolder, Crutch And Cane, WheelchairClass I21 CFR 890.391000
INAHill Holder, WheelchairClass I21 CFR 890.392000
INBAttachment, Commode, WheelchairClass I21 CFR 890.392000
INCCuff, Pusher, WheelchairClass I21 CFR 890.391000
INESling, Overhead Suspension, WheelchairClass I21 CFR 890.391010
INFScale, Platform, WheelchairClass I21 CFR 890.394050
INGElevator, Wheelchair, PortableClass II21 CFR 890.3930293
INIVehicle, Motorized 3-WheeledClass II21 CFR 890.380035322
INKStretcher, Wheeled, PoweredClass II21 CFR 890.36901216
INMChair, With CastersClass I21 CFR 890.31003525
INNChair, Adjustable, MechanicalClass I21 CFR 890.31002623
INOChair, Positioning, ElectricClass II21 CFR 890.3110535
INPTips And Pads, Cane, Crutch And WalkerClass I21 CFR 890.379089
INQTable, PoweredClass I21 CFR 890.37601022
INTPlinthClass I21 CFR 890.352045
INWTable, MechanicalClass I21 CFR 890.3750351
INXBed, Air FluidizedClass II21 CFR 890.5160289
INYBed, Patient Rotation, ManualClass I21 CFR 890.518010
IOADiathermy, Microwave, For Use In Applying Therapeutic Deep HeatClass II21 CFR 890.527540
IOBLamp, Infrared, Non HeatingClass II21 CFR 890.550060
IODComponents, ExerciseClass I21 CFR 890.5350110
IOEBars, Parallel, ExerciseClass I21 CFR 890.537020
IOGTreadmill, MechanicalClass I21 CFR 890.537030
IOLTreadmill, PoweredClass I21 CFR 890.53804319
IONExerciser, Non-MeasuringClass I21 CFR 890.5370432
IOQBed, Flotation Therapy, PoweredClass II21 CFR 890.51705738
IORWheelchair, MechanicalClass I21 CFR 890.385046840
IOYSupport, ArmClass I21 CFR 890.347510
IOZSplint, Abduction, Congenital Hip DislocationClass I21 CFR 890.366540
IPFStimulator, Muscle, PoweredClass II21 CFR 890.58505487
IPGShoe, CastClass I21 CFR 890.302560
IPLWheelchair, StandupClass II21 CFR 890.3900661
IPMCover, LimbClass I21 CFR 890.302561
IPOOrthosis, Pneumatic Structure, RigidClass III21 CFR 890.361000
IPRCrutchClass I21 CFR 890.315045