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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 50 of 71
FDA product codes, page 50 of 71
CodeDevice nameClassRegulationClearancesRecalls
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenClass II21 CFR 866.16402420
NQYVentilator, Continuous, Minimal Ventilatory Support, Home UseClass II21 CFR 868.589500
NQZAntigen, Invasive Fungal PathogensClass II21 CFR 866.305022
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile BearingClass III032
NRBWound Cleaner, UltrasoundClass II21 CFR 878.441090
NRCPad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety ProfileClass I21 CFR 884.542500
NRDUnit, Operative Dental, AccessoriesClass I21 CFR 872.664020
NRFMaterial, Quality Control, Semen AnalysisClass II21 CFR 864.862531
NRHSystem, Breath MeasurementClass I21 CFR 862.182043
NRIAutoantibodies, Nuclear Pore Glycoprotein Gp210Class II21 CFR 866.509020
NRJUltrasound, Skin PermeationClass II21 CFR 878.441010
NRKKit, Test, OlfactoryClass II21 CFR 874.160010
NRLEnzyme Linked Immunoabsorbent Assay, Antibody, B. AnthracisClass II21 CFR 866.304510
NRNLeeches, MedicinalUnclassified30
NRPSirolimus Test SystemClass II21 CFR 862.384056
NRQBlade-Form Endosseous Dental ImplantClass II21 CFR 872.364050
NRSControl Material, Blood Circulating Epithelial Cancer CellClass II21 CFR 864.862511
NRUChair, Dental, Without Operative UnitClass I21 CFR 872.625004
NRVImplantable Radio Frequency Transponder SystemClass II21 CFR 880.630010
NRWStimulator, Intramuscular, AutomaticClass II21 CFR 880.558010
NRXComplement 4d (C4d) And Complement Receptor 1 (Cr1)Class II21 CFR 866.582000
NRYCatheter, Thrombus RetrieverClass II21 CFR 870.125011527
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-GuidedClass III00
NSAOver-The-Counter Automated External DefibrillatorClass III21 CFR 870.531012
NSBPatient Personal Hygiene KitClass I21 CFR 872.6855016
NSCInjector, PenClass II21 CFR 880.586010
NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For RecurrenceClass III00
NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk AssessmentClass II21 CFR 866.603021
NSISystem, Imaging, Esophageal, Wireless, CapsuleClass II21 CFR 876.130070
NSJRestoration, Noble MetalNot classified00
NSKDentures, PartialNot classified00
NSLDentures, FullNot classified00
NSMRestoration, ResinNot classified00
NSNRestoration, Resin, Crown And BridgeNot classified00
NSORestoration, Porcelain-Fused-To-MetalNot classified00
NSPRestoration, PorcelainNot classified01
NSQRestoration, Base MetalNot classified01
NSRProsthesis, OrthodonticNot classified01
NSSElectronic Media, NauseaNot classified00
NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-BlockingClass II21 CFR 866.566040
NSUInstrumentation For Clinical Multiplex Test SystemsClass II21 CFR 862.25701314
NTBSystem, Ablation, Ultrasound And AccessoriesClass II21 CFR 878.440060
NTCNursing Pad, HydrogelClass I21 CFR 880.563010
NTETemporary Carotid Catheter For Embolic CaptureClass II21 CFR 870.12503630
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedClass III04
NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) AssaysClass II21 CFR 866.470080
NTIDrug Metabolizing Enzyme Genotyping SystemsClass II21 CFR 862.3360114
NTKLight Transmission Caries DetectorClass II21 CFR 872.1745120
NTMAntigen, Inflammatory Response Marker, SepsisClass II21 CFR 866.321032
NTNLed Light SourceClass II21 CFR 876.150090
NTORinse, Oral, Antibacterial (By Physical Means)Class II21 CFR 872.558022
NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal CellsClass I21 CFR 864.186011
NTUEvoked Potential Stimulator, ThermalClass II21 CFR 882.187030
NTVMyeloperoxidase, Immunoassay, System, TestClass II21 CFR 866.560021
NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic TestClass II21 CFR 866.407021
NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)Class I21 CFR 880.563010
NTYSystem, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal CancerClass II21 CFR 866.601010
NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, IndicatorClass II21 CFR 876.582010
NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation DetectionClass II21 CFR 866.5900122
NUBColonic Irrigation System, General Well BeingClass III21 CFR 876.522000
NUCLubricant, PersonalClass II21 CFR 884.53002497
NUDVertebroplasty Compound, Calcium BasedClass II21 CFR 888.302700
NUFCatheter, Neurovasculature, Occluding BalloonClass III21 CFR 882.515000
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterClass II21 CFR 882.58902300
NUIUltrasound, Infusion, SystemClass II21 CFR 870.120040
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedClass II21 CFR 878.44003720
NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNot classified01
NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemNot classified00
NUMAutoantibodies, Nuclear Body Protein, Sp100Class II21 CFR 866.509010
NUNBone Grafting Material, Human SourceClass II21 CFR 872.3930150
NUPCream, Nasal, Topical, Mechanical Allergen Particle BarrierClass II21 CFR 880.504580
NUQPad, Menstrual, ReusableClass I21 CFR 884.543510
NURPad, Menstrual, IntralabialClass I21 CFR 884.543500
NUULens, Contact, Orthokeratology, OvernightClass III21 CFR 886.591602
NUVMassager, Vacuum, Light Induced HeatingClass II21 CFR 878.4810200
NUWStimulator, Muscle, Powered, DentalClass II21 CFR 890.585090
NUXCleanser, Denture, PrescriptionClass I21 CFR 872.352000
NVACancer Monitoring Test System, Soluble Mesothelin-Related Peptides, MesotheliomaClass II21 CFR 866.601000
NVBIntraocular, Pressure Measuring DeviceClass III21 CFR 886.428000
NVCBone, HeterograftClass III21 CFR 888.301500
NVEWasher, Cleaner, Automated, EndoscopeClass II21 CFR 876.1500121
NVGTissue Culture, Accessories, DentalClass I21 CFR 864.224000
NVHSuture, Knot, MechanicalClass II21 CFR 878.430010
NVIDiagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune DiseaseClass II21 CFR 862.310011
NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In WomenClass II21 CFR 878.440011
NVKLaser, Dental, Soft TissueClass II21 CFR 878.4810172
NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-BalloonClass II21 CFR 870.125052
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesClass III00
NVOSpacer, Direct Patient InterfaceClass II21 CFR 868.563020
NVPHolding Chambers, Direct Patient InterfaceClass II21 CFR 868.5630163
NVQBacteriophage And Controls, B. Anthracis LysisClass II21 CFR 866.304521
NVRIntervertebral Fusion Device With Bone Graft, Solid-Sphere, LumbarClass III617
NVTTubing And Tubing/Filter FitsClass I21 CFR 884.170001
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemClass I21 CFR 862.210000
NVYPermanent Defibrillator ElectrodesClass III05
NVZPulse Generator, Permanent, ImplantableClass III040
NWAProsthesis, Tracheal, Preformed/MoldedClass II21 CFR 878.372070
NWBEndoscope, Accessories, Narrow Band SpectrumClass II21 CFR 876.1500919
NWEColon Computed Tomography System, Computer Aided DetectionClass II21 CFR 892.205040
NWFDrill, Battery Powered, Subungual HematomaClass I21 CFR 878.482010