Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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 32 of 71
FDA product codes, page 32 of 71
CodeDevice nameClassRegulationClearancesRecalls
JZWNephelometerClass I21 CFR 866.4540111
JZXEquipment, Rocket ImmunoelectrophoresisClass I21 CFR 866.483010
JZYKnife, LaryngealClass I21 CFR 874.442000
JZZSaw, LaryngealClass I21 CFR 874.442000
KAASet, Laryngeal InjectionClass I21 CFR 874.442000
KABTrocar, LaryngealClass I21 CFR 874.442010
KACTube, LaryngectomyClass I21 CFR 874.442041
KADElevator, EntClass I21 CFR 874.442051
KAEForceps, EntClass I21 CFR 874.4420141
KAGHolder, Speculum, EntClass I21 CFR 878.180020
KAHMicrorule, EntClass I21 CFR 874.442000
KAIMirror, EntClass I21 CFR 874.442091
KAJMobilizer, EntClass I21 CFR 874.442000
KAKProbe, EntClass I21 CFR 874.442011
KALRetractor, EntClass I21 CFR 874.442051
KAMCannula, SinusClass I21 CFR 878.4800192
KANChisel, NasalClass I21 CFR 878.480000
KAOCurette, EthmoidClass I21 CFR 874.442000
KAPCurette, NasalClass I21 CFR 874.442010
KAQGouge, Nasal, EntClass I21 CFR 874.442000
KARIrrigator, SinusClass I21 CFR 874.442030
KASKnife, NasalClass I21 CFR 874.442010
KATPerforator, AntrumClass I21 CFR 874.442000
KAWPunch, AntrumClass I21 CFR 874.442000
KAXPunch, EthmoidClass I21 CFR 874.442000
KAYPunch, NasalClass I21 CFR 874.442000
KAZRasp, Frontal-SinusClass I21 CFR 874.442000
KBARasp, NasalClass I21 CFR 874.442000
KBBRongeur, NasalClass I21 CFR 874.442000
KBCSaw, NasalClass I21 CFR 874.442040
KBDScissors, NasalClass I21 CFR 874.442030
KBESnare, NasalClass I21 CFR 874.442000
KBFTrephine, SinusClass I21 CFR 874.442010
KBGTrocar, SinusClass I21 CFR 874.442030
KBHAdenotomeClass I21 CFR 874.442010
KBIBougie, EustachianClass I21 CFR 874.417510
KBJCurette, AdenoidClass I21 CFR 874.442011
KBKCurette, SalpingealClass I21 CFR 874.442000
KBLDepressor, Metal Tongue, SurgicalClass I21 CFR 874.442010
KBMDissector, TonsilClass I21 CFR 874.442010
KBNGag, MouthClass I21 CFR 874.442031
KBOGuillotine, TonsilClass I21 CFR 874.442010
KBPHook, Tonsil SuturingClass I21 CFR 874.442000
KBQKnife, TonsilClass I21 CFR 874.442010
KBRNeedle, Tonsil SuturingClass I21 CFR 874.442000
KBSPunch, AdenoidClass I21 CFR 874.442000
KBTPunch, TonsilClass I21 CFR 874.442000
KBWScrew, OralClass I21 CFR 874.442011
KBXScrew, TonsilClass I21 CFR 874.442000
KBYSet, Filliform, EustachianClass I21 CFR 874.417500
KBZSnare, TonsilClass I21 CFR 874.442010
KCATonsillectomeClass I21 CFR 874.442010
KCBTube, Tonsil SuctionClass I21 CFR 874.442011
KCCBistoury, TrachealClass I21 CFR 874.442000
KCDBougie, Esophageal, EntClass I21 CFR 874.442030
KCECannulae, BronchialClass I21 CFR 878.480000
KCFDilator, Esophageal, EntClass I21 CFR 874.442030
KCGDilator, TrachealClass I21 CFR 874.442011
KCHHook, TrachealClass I21 CFR 874.442000
KCITrocar, TrachealClass I21 CFR 874.442000
KCJApplicator, EntClass I21 CFR 874.522041
KCLBlower, Powder, EntClass I21 CFR 874.522000
KCMDropper, EntClass I21 CFR 874.522012
KCNEar WickClass I21 CFR 874.522046
KCONasal Spray, Ent DeliveryClass I21 CFR 874.522011
KCPSyringe, EntClass I21 CFR 874.522041
KCQTube Impression And MatrixClass I21 CFR 872.657010
KCRFacebowClass I21 CFR 872.322010
KCSPantographClass I21 CFR 872.373000
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass II21 CFR 880.685028238
KCWEpilator, High Frequency, Needle-TypeClass I21 CFR 878.5350430
KCXEpilator, High Frequency, Tweezer-TypeClass I21 CFR 878.5360250
KCYTourniquet, PneumaticClass I21 CFR 878.59103447
KCZProsthesis, Breast, External, Used With AdhesiveClass I21 CFR 878.3800131
KDAProsthesis, Ptfe/Carbon-FiberClass II21 CFR 878.350010
KDCInstrument, Surgical, DisposableClass I21 CFR 878.48006738
KDDKit, Surgical Instrument, DisposableClass I21 CFR 878.480062251
KDGChisel (Osteotome)Class I21 CFR 878.48201114
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And AspirationClass II21 CFR 876.5980232
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemClass II21 CFR 876.5860345217
KDJSet, Administration, For Peritoneal Dialysis, DisposableClass II21 CFR 876.563011361
KDKContainer, Transport, KidneyClass II21 CFR 876.588030
KDLSet, Perfusion, Kidney, DisposableClass II21 CFR 876.5880194
KDMSigmoidoscope, Rigid, Non-ElectricalClass II21 CFR 876.150011
KDNSystem, Perfusion, KidneyClass II21 CFR 876.5880446
KDORongeur, Cystoscopic, HotClass II21 CFR 876.150010
KDPRegulator, VacuumClass II21 CFR 880.6740214
KDQBottle, Collection, VacuumClass II21 CFR 880.67404833
KDTContainer, Specimen Mailer And Storage, SterileClass I21 CFR 864.32501217
KDWContainer, Specimen Mailer And Storage, Temperature Controlled, SterileClass I21 CFR 864.325040
KDXSolution, Decalcifier, Acid ContainingClass I21 CFR 864.401080
KDYAgent, Chelating For DecalcificationClass I21 CFR 864.401000
KDZDevice, Decalcifier, ElectrolyticClass I21 CFR 864.301000
KEAResins, Ion-ExchangeClass I21 CFR 862.223090
KEEOsmium TetroxideClass I21 CFR 864.401000
KEFParaformaldehydeClass I21 CFR 864.401000
KEGLamps, MicroscopeClass I21 CFR 864.360000
KEHMicrometers, MicroscopeClass I21 CFR 864.360000
KEICondensers, MicroscopeClass I21 CFR 864.360000
KEJStages, MicroscopeClass I21 CFR 864.360010