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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 31 of 71
FDA product codes, page 31 of 71
CodeDevice nameClassRegulationClearancesRecalls
JSMCulture Media, Non-Propagating TransportClass I21 CFR 866.239011118
JSNCulture Media, Propagating TransportClass I21 CFR 866.2390130
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarClass II21 CFR 866.17004056
JSPKit, Anaerobic IdentificationClass I21 CFR 866.2660182
JSQChromatography For Bacterial IdentificationClass I21 CFR 862.225030
JSRKit, Identification, DermatophyteClass I21 CFR 866.266010
JSSKit, Identification, EnterobacteriaceaeClass I21 CFR 866.2660499
JSTKit, Fastidious OrganismsClass I21 CFR 866.266066
JSWKit, Identification, Glucose NonfermenterClass I21 CFR 866.266060
JSXKit, Identification, Neisseria GonorrhoeaeClass I21 CFR 866.2660161
JSYKit, Identification, MycobacteriaClass I21 CFR 866.266051
JSZKit, Identification, PseudomonasClass I21 CFR 866.266010
JTAMonitor, Microbial GrowthClass I21 CFR 866.2560110
JTBDevice, Media Dispensing/StackingClass I21 CFR 866.244020
JTCDevice, Microtiter Diluting/DispensingClass I21 CFR 866.2500669
JTLPlasma, Coagulase, Human, Horse And RabbitClass I21 CFR 866.2160120
JTMAnaerobic Box GloveClass I21 CFR 866.212010
JTNSusceptibility Test Discs, AntimicrobialClass II21 CFR 866.162033147
JTODiscs, Strips And Reagents, Microorganism DifferentiationClass I21 CFR 866.266024421
JTQBath, Incubators/Water, AllClass I21 CFR 866.25401211
JTRKit, Quality Control For Culture MediaClass I21 CFR 866.24801246
JTSStains, MicrobiologicClass I21 CFR 864.1850409
JTTSusceptibility Test Powders, AntimicrobialClass II21 CFR 866.1640141
JTWSystem, Transport, AerobicClass I21 CFR 866.2900438
JTXTransport Systems, AnaerobicClass I21 CFR 866.290080
JTYCulture Media, For Isolation Of Pathogenic NeisseriaClass II21 CFR 866.2410839
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/BrothClass II21 CFR 866.1700758
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass II21 CFR 888.3560921984
JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-ConstrainedClass II21 CFR 888.380030
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedClass II21 CFR 888.3800170
JWKAntigen, Positive Control, Cryptococcus NeoformansClass II21 CFR 866.316510
JWLAntigen, Treponema Pallidum For Fta-Abs TestClass II21 CFR 866.383040
JWMSystem, Tomographic, NuclearClass II21 CFR 892.1310171
JWODevice, Blood Volume MeasuringClass II21 CFR 864.595030
JWRAtp Release (Luminescence)Class I21 CFR 864.704000
JWTAntigen, Cf, Aspergillus Spp.Class I21 CFR 866.304050
JWWAntigen, Cf, B. DermatitidisClass II21 CFR 866.306030
JWXKit, Screening, Staphylococcus AureusClass I21 CFR 866.2660207
JWYManual Antimicrobial Susceptibility Test SystemsClass II21 CFR 866.164044178
JWZKit, Screening, TrichomonasClass I21 CFR 866.2660111
JXAKit, Screening, UrineClass I21 CFR 866.2660440
JXBKit, Identification, YeastClass I21 CFR 866.2660166
JXCKit, Screening, YeastClass I21 CFR 866.266060
JXEDevice, Nerve Conduction Velocity MeasurementClass II21 CFR 882.1550271
JXFPlethysmograph, OcularClass III21 CFR 882.179000
JXGShunt, Central Nervous System And ComponentsClass II21 CFR 882.5550259108
JXHMethyl Methacrylate For AneurysmorrhaphyClass II21 CFR 882.503030
JXICuff, NerveClass II21 CFR 882.5275404
JXKCranial Electrotherapy Stimulator To Treat DepressionClass III21 CFR 882.580003
JXLBlock, BiteClass II21 CFR 882.5070280
JXMEnzyme Immunoassay, BenzodiazepineClass II21 CFR 862.31709081
JXNEnzyme Immunoassay, PropoxypheneClass II21 CFR 862.3700222
JXOEnzyme Immunoassay, CocaineClass II21 CFR 862.325060
JXQMonitor, U.V., GlcClass I21 CFR 862.225000
JXRAtomic Absorption Spectrophotometer, General UseClass I21 CFR 862.2850290
JXSBlock, Cutting, Ent, SterileClass I21 CFR 874.354020
JXTCrimper, Wire, Ent, SterileClass I21 CFR 874.354000
JXWDie, Wire Bending, Ent, SterileClass I21 CFR 874.354000
JXXForceps, Wire Closure, Ent, SterileClass I21 CFR 874.354000
JXYJig, Piston Cutting, Ent, SterileClass I21 CFR 874.354000
JXZPunch, Gelfoam, SterileClass I21 CFR 874.354000
JYAScissors, Wire Cutting, Ent, SterileClass I21 CFR 874.354000
JYBVise, Ossicular Finger, SterileClass I21 CFR 874.354000
JYCCannula, EarClass I21 CFR 878.480020
JYDChisel, MastoidClass I21 CFR 878.480010
JYEChisel, Middle-EarClass I21 CFR 874.442010
JYFClamp, Ossicle HoldingClass I21 CFR 874.442000
JYGCurette, EarClass I21 CFR 874.442071
JYHExcavator, EarClass I21 CFR 874.442000
JYIGauge, MastoidClass I21 CFR 874.442000
JYJGauge, MeasuringClass I21 CFR 874.442050
JYKHolder, Ear SpeculumClass I21 CFR 878.180010
JYLHook, Microsurgical EarClass I21 CFR 874.442050
JYMInserter, Myringotomy TubeClass I21 CFR 874.442040
JYNInserter, Sacculotomy TackClass I21 CFR 874.442000
JYOKnife, EarClass I21 CFR 874.442071
JYPKnife, MyringotomyClass I21 CFR 874.442010
JYQLoop, WireClass I21 CFR 874.442020
JYRNipper, MalleusClass I21 CFR 874.442020
JYSPerforator, Ear-LobeClass I21 CFR 874.442030
JYTPick, Microsurgical EarClass I21 CFR 874.442020
JYWPress, VeinClass I21 CFR 874.442010
JYXPunch, AtticClass I21 CFR 874.442000
JYYRasp, EarClass I21 CFR 874.442010
JYZRod, Measuring EarClass I21 CFR 874.442010
JZARongeur, MastoidClass I21 CFR 874.442010
JZBScissors, EarClass I21 CFR 874.442040
JZCSearcher, MastoidClass I21 CFR 874.442000
JZDSnare, EarClass I21 CFR 874.442020
JZESpoon, EarClass I21 CFR 874.442010
JZFTube, Ear SuctionClass I21 CFR 874.442050
JZGSystem, Test, Beta-2-Microglobulin ImmunologicalClass II21 CFR 866.5630536
JZHFactor B, Antigen, Antiserum, ControlClass II21 CFR 866.532061
JZJPrealbumin, Antigen, Antiserum, ControlClass I21 CFR 866.5060111
JZOSystem, Test, Thyroid AutoantibodyClass II21 CFR 866.58709218
JZPPlates, Ouchterlony AgarClass I21 CFR 866.460010
JZQPlates And Equipment, Radial ImmunodiffusionClass I21 CFR 866.480071
JZRSupport GelsClass I21 CFR 866.490020
JZSElectrophoresis InstrumentationClass I21 CFR 866.450060
JZTFluorometerClass I21 CFR 866.4520140