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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 30 of 71
FDA product codes, page 30 of 71
CodeDevice nameClassRegulationClearancesRecalls
JNEGlucose-6-Phosphate (Colorimetric), Phosphohexose IsomeraseClass I21 CFR 862.157000
JNFIon-Exchange Resin, Ehrlich'S Reagent, PorphobilinogenClass I21 CFR 862.159010
JNGRadioimmunoassay, PregnenoloneClass I21 CFR 862.161500
JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate KinaseClass I21 CFR 862.165000
JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol DehydrogenaseClass I21 CFR 862.167000
JNLImmunochemical, Thyroglobulin AutoantibodyClass II21 CFR 866.5870224
JNMImmunochemical, TransferrinClass II21 CFR 866.588033
JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), TrypsinClass I21 CFR 862.172500
JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), TrypsinClass I21 CFR 862.172572
JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)Class I21 CFR 862.178000
JNQQualitative Chemical Reactions, Urinary Calculi (Stone)Class I21 CFR 862.178000
JNSStannous Chloride - Hydrazine, PhospholipidsClass I21 CFR 862.157500
JNTChromatographic, PhospholipidsClass I21 CFR 862.157530
JNXMembrane Osmometry, Plasma OncometryClass I21 CFR 862.153000
JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate IsomeraseClass I21 CFR 862.172000
JNZFluorometric, UroporphyrinClass I21 CFR 862.179000
JOAAcid, Trifluoroacetic, Vitamin A, Hexane ExtractionClass I21 CFR 862.180500
JOBHexane Extraction, Fluorescence, Vitamin EClass I21 CFR 862.181510
JOCColorimetric, XyloseClass I21 CFR 862.182010
JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary BypassClass II21 CFR 870.4270120
JOFPolymer, Ent Synthetic, Porous PolyethyleneClass II21 CFR 874.362060
JOHTube Tracheostomy And Tube CuffClass II21 CFR 868.5800109131
JOJIndicator, Physical/Chemical Sterilization ProcessClass II21 CFR 880.280026524
JOKScissors, Medical, DisposableClass I21 CFR 880.682073
JOLCatheter And Tip, SuctionClass II21 CFR 880.67408416
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicClass II21 CFR 870.2780530
JONTransducer, Apex CardiographicClass II21 CFR 870.284000
JOOTransducer, Heart SoundClass II21 CFR 870.286000
JOPTransducer, UltrasonicClass II21 CFR 870.2880721
JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)Class II21 CFR 870.1750183
JORGenerator, Pulsatile Flow, Cardiopulmonary BypassClass III21 CFR 870.432002
JOSElectrode, ElectrosurgicalClass II21 CFR 878.4400369
JOTElectrode, Gel, ElectrosurgicalClass II21 CFR 878.440090
JOWSleeve, Limb, CompressibleClass II21 CFR 870.580035432
JOXAnalyzer, Heparin, AutomatedClass II21 CFR 864.5680152
JOYDevice, Automated Cell-LocatingClass II21 CFR 864.5260354
JOZSystem, Automated Platelet AggregationClass II21 CFR 864.57003811
JPASystem, Multipurpose For In Vitro Coagulation StudiesClass II21 CFR 864.542518143
JPBHemoglobin MClass II21 CFR 864.741502
JPCHemoglobin F QuantitationClass II21 CFR 864.745510
JPDHemoglobin A2 QuantitationClass II21 CFR 864.7400135
JPEAntithrombin Iii, Two Stage Clotting Time AssayClass II21 CFR 864.706010
JPFProthrombin-Proconvertin And ThrombotestClass II21 CFR 864.773501
JPHTest, Erythrocyte Sedimentation RateClass I21 CFR 864.670070
JPIDevice, Hematocrit MeasuringClass II21 CFR 864.6400159
JPJRed-Cell Indices, CalculatedClass II21 CFR 864.530030
JPKMixture, Hematology Quality ControlClass II21 CFR 864.862519216
JPWPump, Nebulizer, Electrically PoweredClass I21 CFR 874.522010
JPZColorimetric Method, Gamma-Glutamyl TranspeptidaseClass I21 CFR 862.1360330
JQAElectrophoretic, Gamma-Glutamyl Transpeptidase IsoenzymesClass I21 CFR 862.136002
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClass I21 CFR 862.1360520
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClass I21 CFR 862.20503816
JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding CapacityClass I21 CFR 862.141500
JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding CapacityClass I21 CFR 862.141560
JQFBathophenanthroline, Iron Binding CapacityClass I21 CFR 862.141580
JQGRadiometric, Fe59, Iron Binding CapacityClass I21 CFR 862.141550
JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)Class I21 CFR 862.151500
JQIRotating Disc, Plasma ViscometryClass I21 CFR 862.147500
JQJDensitometeric, Protein FractionationClass I21 CFR 862.163010
JQKImmunodiffusion, Protein FractionationClass I21 CFR 862.163010
JQLSpectrophotometric, UroporphyrinClass I21 CFR 862.179000
JQMP-Bromoaniline, XyloseClass I21 CFR 862.182000
JQNColorimetric, MucopolysaccharidesClass I21 CFR 862.150520
JQOBalance, AnalyticalClass I21 CFR 862.205000
JQPCalculator/Data Processing Module, For Clinical UseClass I21 CFR 862.210078218
JQQDialyzerClass I21 CFR 862.205010
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaClass I21 CFR 862.2400180
JQWStation, Pipetting And Diluting, For Clinical UseClass I21 CFR 862.275014036
JQXNephelometer, For Clinical UseClass I21 CFR 862.2700144
JQYPh MeterClass I21 CFR 862.205080
JQZPolarimeterClass I21 CFR 862.205010
JRAMicrotitrator, For Clinical UseClass I21 CFR 862.268010
JRBMicro MixerClass I21 CFR 862.205001
JRCMicro PipetteClass I21 CFR 862.205063
JRERefractometer For Clinical UseClass I21 CFR 862.2800130
JRGBlock, HeatingClass I21 CFR 862.205030
JRICuvette, ThermostatedClass I21 CFR 862.205040
JRJUnit, DryingClass I21 CFR 862.205013
JRKEvaporatorClass I21 CFR 862.205000
JRLUnit, Filter, MembraneClass I21 CFR 862.205090
JRMFreezerClass I21 CFR 862.205071
JROBlender/MixerClass I21 CFR 862.205000
JRQShaker/StirrerClass I21 CFR 862.205080
JRRRegulator, TemperatureClass I21 CFR 862.205040
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)Class I21 CFR 862.205000
JRWAntisera, Fluorescent, B. ParapertussisClass I21 CFR 866.306520
JRYAntiserum, Fluorescent, Epstein-Barr VirusClass I21 CFR 866.323590
JRZMedia, Culture, Amino Acid AssayClass I21 CFR 866.235000
JSACulture Media, Antibiotic AssayClass I21 CFR 866.235080
JSBCulture Media, Vitamin AssayClass I21 CFR 866.235000
JSCCulture Media, General Nutrient BrothClass I21 CFR 866.2350525
JSDCulture Media, Selective BrothClass I21 CFR 866.2360262
JSECulture Media, Multiple Biochemical TestClass I21 CFR 866.2320530
JSFCulture Media, Single Biochemical TestClass I21 CFR 866.2320870
JSGCulture Media, Non-Selective And Non-DifferentialClass I21 CFR 866.230020929
JSHCulture Media, Non-Selective And DifferentialClass I21 CFR 866.23201462
JSICulture Media, Selective And DifferentialClass I21 CFR 866.236028524
JSJCulture Media, Selective And Non-DifferentialClass I21 CFR 866.23603076
JSKSupplement, Culture MediaClass I21 CFR 866.2450706
JSLCulture Media, Anaerobic TransportClass I21 CFR 866.239080