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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 13 of 71
FDA product codes, page 13 of 71
CodeDevice nameClassRegulationClearancesRecalls
FJNStabilizer, ShuntClass II21 CFR 876.554000
FJOPlier, TubeClass I21 CFR 876.554000
FJPAdaptor, YClass II21 CFR 876.582001
FJQConnector, ShuntClass I21 CFR 876.554030
FJRForceps, DisconnectClass I21 CFR 876.554000
FJSCatheter, Peritoneal, Long-Term IndwellingClass II21 CFR 876.5630488
FJTIntracatheter, DialysisClass II21 CFR 876.582050
FJWRing, JointClass I21 CFR 876.554000
FJXRing, CrimpClass I21 CFR 876.554000
FJYPlier, CrimpClass I21 CFR 876.554000
FJZDeclotting Tray, Kit (Including Contents)Class II21 CFR 876.582030
FKADilator, VesselClass II21 CFR 876.554030
FKBConnector, Blood Tubing, Infusion TClass II21 CFR 876.582021
FKCClamp, CannulaClass I21 CFR 876.554010
FKDCanister, CoilClass II21 CFR 876.582010
FKETie, DialysisClass I21 CFR 876.582000
FKFGun, Tie, DialysisClass I21 CFR 876.582000
FKGTray, Start/Stop (Including Contents), DialysisClass I21 CFR 876.5820611
FKHSolution-Test Standard-Conductivity, DialysisClass II21 CFR 876.582082
FKISet, Dialyzer HolderClass II21 CFR 876.582030
FKJFilter, Blood, DialysisClass II21 CFR 876.582050
FKKClamp, LineClass I21 CFR 876.473060
FKLInsert, Pump, BloodClass II21 CFR 876.582010
FKMAdaptor, FistulaClass II21 CFR 876.582000
FKNAdaptor, ShuntClass II21 CFR 876.554040
FKOCatheter, Peritoneal Dialysis, Single UseClass II21 CFR 876.5630160
FKPSystem, Dialysate Delivery, Single PatientClass II21 CFR 876.58205012
FKQSystem, Dialysate Delivery, Central Multiple PatientClass II21 CFR 876.5820612
FKRSubsystem, ProportioningClass II21 CFR 876.58201210
FKTSystem, Dialysate Delivery, Sorbent RegeneratedClass II21 CFR 876.5600190
FKWTip, VesselClass II21 CFR 876.554030
FKXSystem, Peritoneal, Automatic DeliveryClass II21 CFR 876.56308351
FKYConnector, Tubing, DialysateClass II21 CFR 876.582040
FLAMonitor, Temperature, DialysisClass II21 CFR 876.582030
FLBMeter, Conductivity, Induction, Remote TypeClass II21 CFR 876.582060
FLCStation, Dialysis Control, Negative Pressure TypeClass II21 CFR 876.582040
FLDApparatus, Hemoperfusion, SorbentClass II21 CFR 876.5870117
FLESterilizer, SteamClass II21 CFR 880.688018518
FLFSterilizer, Ethylene-Oxide GasClass II21 CFR 880.6860268
FLGCleaner, Ultrasonic, Medical InstrumentClass I21 CFR 880.6150197
FLHWasher Of Body Waste ReceptaclesClass I21 CFR 880.680000
FLICabinet, Ethylene-Oxide Gas AeratorClass II21 CFR 880.610080
FLJUnit, Airflow, LaminarClass II21 CFR 878.507000
FLKThermometer, Clinical MercuryClass II21 CFR 880.2920330
FLLContinuous Measurement ThermometerClass II21 CFR 880.291079819
FLNMonitor, Electric For Gravity Flow Infusion SystemsClass II21 CFR 880.2420390
FLSMonitor, Apnea, Facility UseClass II21 CFR 868.2377162
FMADepressor, Tongue, Non-SurgicalClass I21 CFR 880.623050
FMCPatient Examination GloveClass I21 CFR 880.6250340
FMEGown, ExaminationClass I21 CFR 880.626551
FMFSyringe, PistonClass II21 CFR 880.5860752305
FMGStopcock, I.V. SetClass II21 CFR 880.544089207
FMHContainer, Specimen, SterileClass I21 CFR 864.32502321
FMINeedle, Hypodermic, Single LumenClass II21 CFR 880.5570694311
FMJManometer, Spinal-FluidClass II21 CFR 880.250065
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureClass II21 CFR 878.485011117
FMLChair, Blood DonorClass I21 CFR 880.614020
FMPProtector, Skin PressureClass I21 CFR 880.6450234
FMQRestraint, ProtectiveClass I21 CFR 880.676013433
FMRDevice, Transfer, Patient, ManualClass I21 CFR 880.678550
FMSBed, Pediatric Open HospitalClass II21 CFR 880.5140275
FMTWarmer, Infant RadiantClass II21 CFR 880.51309236
FMWCover, Mattress (Medical Purposes)Class I21 CFR 880.6190143
FMZIncubator, NeonatalClass II21 CFR 880.54008643
FNCTent, Pediatric AerosolClass II21 CFR 868.571010
FNGLift, Patient, Ac-PoweredClass II21 CFR 880.55002123
FNJBed, ManualClass I21 CFR 880.5120397
FNKBed, Hydraulic, Adjustable HospitalClass I21 CFR 880.511014
FNLBed, Ac-Powered Adjustable HospitalClass II21 CFR 880.510070155
FNMMattress, Air Flotation, Alternating PressureClass II21 CFR 880.555010213
FNNNipple, Lambs FeedingClass I21 CFR 880.564000
FNPUrinalClass I21 CFR 880.673010
FNSRing CutterClass I21 CFR 880.620000
FNWPad, KellyClass II21 CFR 878.437020
FNYBasin, EmesisClass I21 CFR 880.673091
FOABoard, CardiopulmonaryClass I21 CFR 880.608030
FOBBedpanClass I21 CFR 880.673050
FOCBag, Urine Collection, NewbornClass II21 CFR 876.525040
FODDevice, Occlusion, UmbilicalClass I21 CFR 880.595000
FOGHood, Oxygen, InfantClass I21 CFR 868.570090
FOHMattress, Water, Temperature RegulatedClass I21 CFR 880.556060
FOKPad, Neonatal EyeClass I21 CFR 880.527050
FONBag, Drainage, With Adhesive, OstomyClass I21 CFR 876.590035
FOSCatheter, Umbilical ArteryClass II21 CFR 880.5200347
FOXStand, InfusionClass I21 CFR 880.6990365
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass II21 CFR 880.5200508394
FPASet, Administration, IntravascularClass II21 CFR 880.54401,1751,089
FPBFilter, Infusion LineClass II21 CFR 880.5440998
FPDTube, FeedingClass II21 CFR 876.59805924
FPFBottle, Hot/Cold WaterClass I21 CFR 880.608510
FPKTubing, Fluid DeliveryClass II21 CFR 880.54406428
FPLIncubator, Neonatal TransportClass II21 CFR 880.5410251
FPOStretcher, WheeledClass II21 CFR 880.69105076
FPPStretcher, Hand-CarriedClass I21 CFR 880.69003912
FPSBoard, BedClass I21 CFR 880.607014
FPXStrip, Adhesive, Closure, SkinClass I21 CFR 880.5240351
FPYSheet, BurnClass I21 CFR 880.5180171
FQAScale, Surgical SpongeClass I21 CFR 880.274011
FQHLavage, JetClass II21 CFR 880.54755329
FQJSupport, Scrotal, TherapeuticClass I21 CFR 880.582000