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 2 of 71
FDA product codes, page 2 of 71
CodeDevice nameClassRegulationClearancesRecalls
CADVaporizer, Anesthesia, Non-HeatedClass II21 CFR 868.58805713
CAEAirway, Oropharyngeal, AnesthesiologyClass I21 CFR 868.51105776
CAFNebulizer (Direct Patient Interface)Class II21 CFR 868.563050936
CAGCirculator, Breathing-CircuitClass II21 CFR 868.525000
CAHFilter, Bacterial, Breathing-CircuitClass II21 CFR 868.526020228
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Class I21 CFR 868.5240184205
CAKMicrofilter, Blood TransfusionClass II21 CFR 880.5440361
CALLaryngoscope, Non-RigidClass I21 CFR 868.5530811
CAMYoke Assembly, Medical GasClass I21 CFR 868.688580
CANRegulator, Pressure, Gas CylinderClass I21 CFR 868.27005517
CAOAirway, Esophageal (Obturator)Class II21 CFR 868.565060
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Class II21 CFR 868.2600780
CARMonitor, Spinal-Fluid Pressure, Electrically PoweredClass II21 CFR 880.246030
CATCannula, Nasal, OxygenClass I21 CFR 868.5340426
CAWGenerator, Oxygen, PortableClass II21 CFR 868.544028944
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedClass I21 CFR 868.2340241
CAZAnesthesia Conduction KitClass II21 CFR 868.5140156220
CBAMonitor, Air Embolism, UltrasonicClass II21 CFR 868.202510
CBCBottle, Collection And Trap, Breathing System (Uncalibrated)Class II21 CFR 880.674030
CBDBottle, Collection, Breathing System (Calibrated)Class II21 CFR 880.674030
CBFChamber, HyperbaricClass II21 CFR 868.5470693
CBGSpreader, CuffClass I21 CFR 868.576010
CBHDevice, Fixation, Tracheal TubeClass I21 CFR 868.57704712
CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)Class II21 CFR 868.57403410
CBKVentilator, Continuous, Facility UseClass II21 CFR 868.5895505323
CBLAbsorbent, Carbon-DioxideClass I21 CFR 868.530057
CBNApparatus, Gas-ScavengingClass II21 CFR 868.5430435
CBOAttachment, Intermittent Mandatory Ventilation (Imv)Class II21 CFR 868.5955150
CBPValve, Non-RebreathingClass II21 CFR 868.58701037
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Class II21 CFR 868.1500220
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Class II21 CFR 868.170053
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Class II21 CFR 868.1620170
CBTArterial Blood Sampling KitClass I21 CFR 868.11005823
CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, IndwellingClass II21 CFR 868.1170101
CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, IndwellingClass II21 CFR 868.1150150
CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, IndwellingClass II21 CFR 868.1200230
CCIAnalyzer, Gas, Nitrogen, Gaseous-PhaseClass II21 CFR 868.169020
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-PhaseClass II21 CFR 868.1430281
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass II21 CFR 868.140030784
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseClass II21 CFR 868.17201225
CCMPlethysmograph, PressureClass II21 CFR 868.1750110
CCNFlowmeter, Nonback-Pressure Compensated, Bourdon GaugeClass I21 CFR 868.230091
CCOBed, Rocking, Breathing AssistClass II21 CFR 868.518000
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Class I21 CFR 868.5640629
CCTApplicator (Laryngo-Tracheal), Topical AnesthesiaClass II21 CFR 868.5170106
CCWLaryngoscope, RigidClass I21 CFR 868.55406453
CCXSupport, Patient PositionClass I21 CFR 868.682087
CCYZimmerman (Spectrophotometric), 17-KetosteroidsClass I21 CFR 862.143010
CCZZimmerman/Norymberski, 17-Ketogenic SteroidsClass I21 CFR 862.138510
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/SerotoninClass I21 CFR 862.139031
CDBPorter Silber Hydrazone, 17-HydroxycorticosteroidsClass I21 CFR 862.138520
CDCL-Leucyl B-Naphthylamide, Leucine AminopeptidaseClass I21 CFR 862.146000
CDDRadioassay, Vitamin B12Class II21 CFR 862.18107812
CDEChromatographic Separation/Zimmerman, 17-KetosteroidsClass I21 CFR 862.143000
CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/VanillinClass I21 CFR 862.1795120
CDGChromatography Separation/Zimmerman 17-Ketogenic SteroidsClass I21 CFR 862.138510
CDHAcid, Uric, Phosphotungstate ReductionClass I21 CFR 862.1775150
CDKAcid, Vanilmandelic, Electrophoretic SeparationClass I21 CFR 862.179500
CDLBerthelot Indophenol, Urea NitrogenClass II21 CFR 862.1770161
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Class I21 CFR 862.178591
CDNUrease, Photometric, Urea NitrogenClass II21 CFR 862.1770162
CDOAcid, Uric, Uricase (U.V.)Class I21 CFR 862.1775311
CDPRadioimmunoassay, Total TriiodothyronineClass II21 CFR 862.171014420
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClass II21 CFR 862.17701176
CDR1-Nitroso-2-Naphthol (Fluorometric), Free TyrosineClass I21 CFR 862.173010
CDSElectrode, Ion Specific, Urea NitrogenClass II21 CFR 862.1770151
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClass I21 CFR 862.170515120
CDWDiacetyl-Monoxime, Urea NitrogenClass II21 CFR 862.1770212
CDXRadioimmunoassay, Total ThyroxineClass II21 CFR 862.17001211
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClass I21 CFR 862.16808919
CEATlc Chromatographic Separation TriglyceridesClass I21 CFR 862.170500
CECRadioimmunoassay, Free ThyroxineClass II21 CFR 862.16959212
CED5-Amp-Phosphate Release (Colorimetric Test), 5'-NucleotidaseClass I21 CFR 862.152090
CEERadioimmunoassay, Thyroxine-Binding GlobulinClass II21 CFR 862.1685251
CEFElectrophoretic, Protein FractionationClass I21 CFR 862.1630290
CEIUranyl Acetate/Zinc Acetate, SodiumClass II21 CFR 862.166540
CEJTetraphenyl Borate, Colorimetry, PotassiumClass II21 CFR 862.1600160
CEKBiuret (Colorimetric), Total ProteinClass II21 CFR 862.163511610
CELAmmonium Molybdate And Ammonium Vanadate, PhospholipidsClass I21 CFR 862.157530
CEMElectrode, Ion Specific, PotassiumClass II21 CFR 862.16008963
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Class I21 CFR 862.1550115
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClass I21 CFR 862.15801058
CEPRadioimmunoassay, Luteinizing HormoneClass I21 CFR 862.14851436
CEQMolybdenum Blue Method, PhospholipidsClass I21 CFR 862.157510
CER2,4-Dinitrophenylhydrazine, Lactate DehydrogenaseClass II21 CFR 862.144010
CESChromogenesis, Phenylketones (Urinary, Non-Quant.)Class I21 CFR 862.156000
CETOlive Oil Emulsion (Turbidimetric), LipaseClass I21 CFR 862.1465150
CEWRadioimmunoassay, Parathyroid HormoneClass II21 CFR 862.15458621
CEXChromatographic Separation, Lactate Dehydrogenase IsoenzymesClass II21 CFR 862.144580
CFAElectrode, Ion Specific, MagnesiumClass I21 CFR 862.149520
CFBChromatographic Derivative, Total LipidsClass I21 CFR 862.147000
CFDSulfophosphovanillin, Colorimetry, Total LipidsClass I21 CFR 862.147040
CFEElectrophoretic, Lactate Dehydrogenase IsoenzymesClass II21 CFR 862.1445280
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)Class II21 CFR 866.5510294
CFGOil Emulsion/Thymolphthalein (Titrimetric), LipaseClass I21 CFR 862.146520
CFHTetrazolium Int Dye-Diaphorase, Lactate DehydrogenaseClass II21 CFR 862.1440130
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClass II21 CFR 862.14401118
CFLRadioimmunoassay, Human Growth HormoneClass I21 CFR 862.1370365
CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)Class I21 CFR 862.1410210
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Class II21 CFR 866.55106120