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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 51 of 71
FDA product codes, page 51 of 71
CodeDevice nameClassRegulationClearancesRecalls
NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)Class II21 CFR 866.566020
NWIElectrosurgical Electrode KitClass II21 CFR 876.430001
NWJSuture, Recombinant TechnologyClass II21 CFR 878.449491
NWMImmunoassay, Anti-Seizure DrugClass II21 CFR 862.335050
NWNLaparoscopic Bone Anchor Urethropexy Instrument KitClass II21 CFR 888.304001
NWOKit, Catheter, Urinary (Exludes Hiv Testing)Class II21 CFR 876.513013
NWPSuprapubic Cystostomy Catheter KitClass II21 CFR 876.509000
NWSKit, Choledochoscope, Flexible And RigidClass II21 CFR 876.150010
NWTEndoscopic Cholangiogram KitClass II21 CFR 876.150000
NWUEndoscope Introducer KitClass II21 CFR 876.1500325
NWVLaparoscopic Accessories, GynecologicClass I21 CFR 884.172007
NWWHysteroscope AccessoriesClass I21 CFR 884.169000
NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/ScoringClass III03
NWYTest, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNot classified02
NWZGas Chromatography, Bacillus Anthracis Membrane Fatty AcidsClass II21 CFR 866.304510
NXATracheotomy Care KitClass II21 CFR 868.5800112
NXBDispenser, Solid MedicationClass I21 CFR 890.505031
NXCAligner, SequentialClass II21 CFR 872.54701452
NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) RnaClass II21 CFR 866.333230
NXEWalker, Mechanical, Poly Vinyl Chloride (Pvc)Class I21 CFR 890.382510
NXFGas, Laser GeneratingClass I21 CFR 878.481000
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And DeletionClass III00
NXHNursing Pad, Cohesive GelClass I21 CFR 880.563010
NXJDenture, Cosmetic OnlyNot classified00
NXMProsthesis, Eyelid Spacer/Graft, BiologicClass II21 CFR 886.313020
NXOCalprotectin, FecalClass II21 CFR 866.5180153
NXQReminder, MedicationClass I21 CFR 890.505021
NXRFixation, Vision Training, BinocularClass I21 CFR 886.129010
NXTProsthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingClass III06
NXVDiagnostic Light, Soft Tissue DetectorClass II21 CFR 872.6350120
NXWScaffold, Infrapopliteal, AbsorbableClass III00
NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus AureusClass I21 CFR 866.370041
NXZDental Hygiene KitClass I21 CFR 872.685500
NYCDental Prophylaxis KitClass I21 CFR 872.456500
NYDEndodontic KitClass II21 CFR 872.382001
NYEFixture Mount KitClass I21 CFR 872.398000
NYFGingival Retraction KitClass I21 CFR 872.456500
NYGLapping Tool KitClass I21 CFR 872.456500
NYHPlaque Disclosing KitClass II21 CFR 872.174010
NYIClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast CancerClass II21 CFR 866.6040101
NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)Class II21 CFR 886.138510
NYLHandpiece, Air-Powered, Root Canal IrrigationClass I21 CFR 872.420050
NYNStimulator, Electrical, Transcutaneous, For ArthritisClass II21 CFR 882.589080
NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii AntibodyClass II21 CFR 866.510040
NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast CancerClass II21 CFR 864.189006
NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)Class II21 CFR 878.401510
NYTProsthesis, Tracheal, Expandable, PolymericClass II21 CFR 878.372030
NYUCatheter, Hemodialysis, Implanted, CoatedClass II21 CFR 876.5540230
NYVGastrointestinal Motility System, CapsuleClass II21 CFR 876.172550
NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain ReliefClass II21 CFR 882.589000
NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic PurposesClass II21 CFR 882.589000
NYYStimulator, Muscle, Powered, With Limited Output, For RehabilitationClass II21 CFR 890.585000
NYZStimulator, Muscle, Powered, With Limited Output, For Muscle ConditioningClass II21 CFR 890.585000
NZAAccessories, Germicide, Cleaning, For EndoscopesClass II21 CFR 876.1500111
NZBQuality Control Material, Genetics, DnaClass II21 CFR 866.591040
NZCStent, Urethral, Prostatic, Semi-PermanentClass III00
NZDStretcher, Patient RestraintClass I21 CFR 880.690012
NZEHyperthermia MonitorClass II21 CFR 870.590061
NZFStatic Electricity-Emitting Device, Cosmetic UseNot classified00
NZGBassinet, HospitalClass II21 CFR 880.514502
NZHMedication Management System, RemoteClass II21 CFR 880.631520
NZJRespirator, N95, For Use By The General Public In Public Health Medical EmergenciesClass II21 CFR 880.626022
NZKStimulator, Low Electric Field, Tumor TreatmentClass III00
NZPSealant, MicrobialClass II21 CFR 878.437040
NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, YeastClass I21 CFR 866.266030
NZTDosimeter, Ionizing Radiation, ImplantedClass II21 CFR 892.505075
NZUCollector, Urine, Powered, Non Indwelling CatheterClass I21 CFR 876.525011
NZWHeparin, Vascular Access FlushClass II21 CFR 880.5200744
NZXWater, Vascular Access FlushClass II21 CFR 880.520000
NZYLight, Lymphedema Reduction, Low EnergyClass II21 CFR 890.550010
OAAAid, Visual, For NauseaNot classified00
OABLow Energy Direct Current Thermal Ablation SystemClass II21 CFR 878.4400154
OACPlethysmograph, Air Displacement For Body Composition AnalysisClass II21 CFR 870.277030
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterClass III022
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationClass III034
OAFImplant, Hearing, Active, Middle Ear, Totally ImplantedClass III02
OAGGarment, Storage, Peritoneal Dialysis CatheterClass I21 CFR 890.505000
OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus FaecalisClass I21 CFR 866.374041
OAIAssay, Enterovirus Nucleic AcidClass II21 CFR 866.322520
OAJCatheter, Drainage, Intraoral/ExtraoralClass I21 CFR 878.420010
OALExercise Equipment, Powered, Emg-TriggeredClass II21 CFR 890.137510
OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1Class I21 CFR 862.155021
OANOrthosis, Cranial, Laser ScanClass II21 CFR 882.5970230
OAOCord Blood Processing System And Storage ContainerClass II21 CFR 864.990000
OAPLaser, Comb, HairClass II21 CFR 890.55001141
OAQElectronic Media, HyperacusisNot classified00
OARInjector, Vertebroplasty (Does Not Contain Cement)Class I21 CFR 888.4200126
OASX-Ray, Tomography, Computed, DentalClass II21 CFR 892.17501357
OATImplant, Endosseous, OrthodonticClass II21 CFR 872.3640523
OAUDes-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular CarcinomaClass II21 CFR 866.603010
OAVMycophenolic Acid Test SystemClass II21 CFR 862.384030
OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaHumanitarian device exemption01
OAXPlasmodium Spp. Detection ReagentsClass II21 CFR 866.340210
OAYLight Source System, Diagnostic EndoscopicClass III01
OAZOne-Way Air-Leak ValveHumanitarian device exemption00
OBAPolymerizing, Neurovascular Embolization MaterialHumanitarian device exemption00
OBBKit, Conception-Assist, Home UseClass II21 CFR 884.525040
OBCOccluder, Internal Vessel, TemporaryClass III018
OBDBarrier, Adhesion, CardiovascularClass III00
OBEAnti-Ss-A 52 AutoantibodiesClass II21 CFR 866.510030