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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 27 of 71
FDA product codes, page 27 of 71
CodeDevice nameClassRegulationClearancesRecalls
IYEAccelerator, Linear, MedicalClass II21 CFR 892.5050738563
IYGBetatron, MedicalClass II21 CFR 892.505000
IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-RayClass II21 CFR 892.590011
IYICollimator, Orthovoltage, Therapeutic X-RayClass II21 CFR 892.590020
IYJCollimator, Low Voltage, Therapeutic X-RayClass II21 CFR 892.590000
IYKCollimator, High Voltage, Therapeutic X-RayClass II21 CFR 892.590000
IYLCollimator, Dermatological, Therapeutic X-RayClass II21 CFR 892.590010
IYMSystem, Telethermographic, InfraredClass III21 CFR 884.298080
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass II21 CFR 892.15501,185299
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass II21 CFR 892.156089583
IYPPhantom, Anthropomorphic, NuclearClass I21 CFR 892.137030
IYQPhantom, Flood Source, NuclearClass I21 CFR 892.138000
IYTSystem, Rebreathing, RadionuclideClass II21 CFR 892.1390490
IYWScanner, Rectilinear, NuclearClass I21 CFR 892.130040
IYXCamera, Scintillation (Gamma)Class I21 CFR 892.11001307
IYYSynchronizer, Electrocardiograph, NuclearClass I21 CFR 892.141030
IYZBed, Scanning, NuclearClass I21 CFR 892.1350120
IZCCamera, PositronClass I21 CFR 892.111000
IZDProbe, Uptake, NuclearClass I21 CFR 892.13203010
IZFSystem, X-Ray, TomographicClass II21 CFR 892.1740426
IZGSystem, X-Ray, PhotofluorographicClass II21 CFR 892.173070
IZHSystem, X-Ray, MammographicClass II21 CFR 892.171017614
IZISystem, X-Ray, AngiographicClass II21 CFR 892.1600199259
IZJCamera, X-Ray, Fluorographic, Cine Or SpotClass II21 CFR 892.1620122
IZLSystem, X-Ray, MobileClass II21 CFR 892.1720237170
IZOGenerator, High-Voltage, X-Ray, DiagnosticClass I21 CFR 892.17001634
IZPProgrammer, Changer, Film/Cassette, RadiographicClass II21 CFR 892.1870100
IZQInjector, Contrast Medium, AutomaticClass II21 CFR 870.1650233
IZSAperture, RadiographicClass II21 CFR 892.161010
IZTCone, RadiographicClass II21 CFR 892.161010
IZWCollimator, Automatic, RadiographicClass II21 CFR 892.1610233
IZXCollimator, Manual, RadiographicClass II21 CFR 892.1610174
IZZTable, Radiographic, Non-Tilting, PoweredClass II21 CFR 892.19802919
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedClass II21 CFR 892.1650300223
JABSystem, X-Ray, Fluoroscopic, Non-Image-IntensifiedClass II21 CFR 892.166020
JACSystem, X-Ray, Film Marking, RadiographicClass I21 CFR 892.16401815
JADSystem, Therapeutic, X-RayClass II21 CFR 892.59005312
JAEMicrotron, MedicalClass II21 CFR 892.505000
JAFMonitor, Ultrasonic, NonfetalClass II21 CFR 892.1540388
JAGIlluminator, Radiographic-Film, Explosion-ProofClass I21 CFR 892.189000
JAICouch, Radiation Therapy, PoweredClass II21 CFR 892.57703218
JAKSystem, X-Ray, Tomography, ComputedClass II21 CFR 892.1750825871
JAMScanner, Whole Body, NuclearClass I21 CFR 892.133030
JANCounter, Whole Body, NuclearClass I21 CFR 892.113000
JAOScanner, FluorescentClass II21 CFR 892.122020
JAQSystem, Applicator, Radionuclide, Remote-ControlledClass II21 CFR 892.570020852
JARPhantom, Test-Pattern, RadionuclideClass I21 CFR 892.142000
JAXPneumotachometerClass II21 CFR 868.255081
JAYSupport, Breathing TubeClass I21 CFR 868.5280192
JAZProsthesis, Facial, Mandibular ImplantClass II21 CFR 874.369520
JBBSolubility, Hemoglobin, AbnormalClass II21 CFR 864.782520
JBDSystem, Analysis, Electrophoretic HemoglobinClass II21 CFR 864.7440263
JBECell Enzymes (Erythrocytic And Leukocytic)Class II21 CFR 864.710010
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), ScreeningClass II21 CFR 864.736051
JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), SpotClass II21 CFR 864.736000
JBHGlucose-6-Phosphate Dehydrogenase (Erythrocytic), MicromethodClass II21 CFR 864.736000
JBIGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase InhibitionClass II21 CFR 864.736000
JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin ReductionClass II21 CFR 864.736000
JBKGlucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. KineticClass II21 CFR 864.736000
JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), QuantitativeClass II21 CFR 864.736022
JBMGlucose-6-Phosphate Dehydrogenase (Erythrocytic), ElectrophoresisClass II21 CFR 864.736000
JBNFibrin Monomer ParacoagulationClass II21 CFR 864.730020
JBOTest, Euglobulin LysisClass II21 CFR 864.727510
JBPActivated Whole Blood Clotting TimeClass II21 CFR 864.71402410
JBQAntithrombin Iii QuantitationClass II21 CFR 864.7060560
JBRTest, Heparin NeutralizationClass II21 CFR 864.752530
JBSTimer, General LaboratoryClass I21 CFR 862.205002
JBTTimer, CoagulationClass II21 CFR 864.540000
JBWRed-Cell Indices, MeasuredClass II21 CFR 864.530000
JBXAggregrometer, PlateletClass II21 CFR 864.6675120
JBYAggregometer, Platelet, Photo-Optical ScanningClass II21 CFR 864.667520
JBZStudy, Platelet AdhesiveClass II21 CFR 864.665030
JCADevice, Bleeding TimeClass II21 CFR 864.610071
JCBDetergentClass I21 CFR 864.401003
JCCPh BufferClass I21 CFR 864.401072
JCESolution, IsotonicClass I21 CFR 864.401070
JCFLymphocyte Separation MediumClass I21 CFR 864.8500124
JCGFluid, Diluting, Manual CellClass I21 CFR 864.820010
JCHEsteraseClass I21 CFR 864.185000
JCIAcid Phosphatase, CytochemicalClass I21 CFR 864.185000
JCJAlkaline PhosphataseClass I21 CFR 864.766000
JCMControl, Hemoglobin, AbnormalClass II21 CFR 864.7415121
JCNControl, Cell Counter, Normal And AbnormalClass II21 CFR 864.8625123
JCOBothrops Atrox ReagentClass II21 CFR 864.810070
JCQProsthesis, EsophagusClass II21 CFR 878.361010
JCTProsthesis, Tracheal, ExpandableClass II21 CFR 878.37204561
JCWProsthesis, Penis, InflatableClass III21 CFR 876.3350019
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredClass II21 CFR 878.47807724
JCYCatheter, InfusionClass I21 CFR 878.4200143
JDBProsthesis, Elbow, Semi-Constrained, CementedClass II21 CFR 888.31602726
JDCProsthesis, Elbow, Constrained, CementedClass II21 CFR 888.31502921
JDDProsthesis, Upper FemoralClass II21 CFR 888.336000
JDGProsthesis, Hip, Femoral Component, Cemented, MetalClass II21 CFR 888.33605918
JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/PolyacetalClass III21 CFR 888.338001
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass II21 CFR 888.3350565255
JDJMesh, Surgical, Acetabular, Hip, ProsthesisClass II21 CFR 878.330070
JDKProsthesis, Hip, Cement RestrictorClass II21 CFR 878.33005412
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Class III21 CFR 888.3320455
JDNImplant, Fixation Device, SpinalClass II21 CFR 888.306060
JDODevice, Fixation, Proximal Femoral, ImplantClass II21 CFR 888.3030238