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 40 of 71
FDA product codes, page 40 of 71
CodeDevice nameClassRegulationClearancesRecalls
LOQDevice, General Purpose, HematologyClass II21 CFR 866.601011
LOTPulse-Generator, Program ModuleClass III00
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousClass II21 CFR 870.510088121
LOZArtificial HeartClass III05
LPASystem, Esophageal PacingClass III05
LPBCardiac Ablation Percutaneous CatheterClass III021
LPCDevice, Angioplasty, Laser, CoronaryClass III04
LPFProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, CementedClass III00
LPGMaterial, Dressing, Surgical, Polylactic AcidClass III07
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedClass II21 CFR 888.3358565297
LPIKit, Assay, Progesterone ReceptorClass III21 CFR 864.186000
LPJKit, Assay, Estrogen ReceptorClass III21 CFR 864.186001
LPLLenses, Soft Contact, Daily WearClass II21 CFR 886.592548770
LPMLenses, Soft Contact, Extended WearClass III21 CFR 886.5925026
LPNAccessories, Soft Lens ProductsClass II21 CFR 886.592812123
LPOGases Used Within Eye To Place Pressure On Detached RetinaClass III21 CFR 886.427001
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaClass II21 CFR 868.250021
LPQStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic DeepClass II21 CFR 890.587002
LPSUrinary Homocystine (Nonquantitative) Test SystemClass II21 CFR 862.13772918
LPTSystem, Test, Urinary Methylmalonic AcidClass II21 CFR 862.150901
LPWSystem, Test, OxalateClass I21 CFR 862.154210
LPXRadioceptor Assay, Neuroleptic DrugsClass II21 CFR 862.364500
LPZContainer, Frozen Donor Tissue StorageUnclassified60
LQAMedia, Reusable ImageClass I21 CFR 892.184010
LQBMedical Computers And Software For Ophthalmic UseClass III20
LQCLithotriptor, Biliary MechanicalClass II21 CFR 876.4500117
LQDRecorder, Attention Task PerformanceUnclassified110
LQEImplant, Corneal, RefractiveClass III03
LQFDna-Reagents, Mycobacterium Spp.Class I21 CFR 866.3370152
LQGDna-Reagents, Mycoplasma Spp.Class I21 CFR 866.337511
LQHDna-Reagents, LegionellaClass II21 CFR 866.330020
LQIHepatitis Delta Serological ReagentsClass III00
LQJLens, Surgical, Laser, Accesssory, Ophthalmic LaserClass II21 CFR 886.4390131
LQKHome Uterine Activity MonitorClass II21 CFR 884.273061
LQLGram Positive Identification PanelClass I21 CFR 866.2660117
LQMGram Negative Identification PanelClass I21 CFR 866.266072
LQNLatex Agglutination Assay, RubellaClass II21 CFR 866.3510130
LQODna-Reagents, Campylobacter Spp.Class I21 CFR 866.311040
LQPCampylobacter Spp.Class I21 CFR 866.3110121
LQQColumns, Immunoadsorption In Extracorporeal SystemsClass III11
LQRDislodger, Stone, BiliaryClass II21 CFR 876.50103811
LQSSpermatocele, AlloplasticUnclassified10
LQWTest, Temperature DiscriminationClass I21 CFR 882.120030
LQXDevice, Finger-SuckingClass I21 CFR 890.347520
LQYLocator, Root ApexUnclassified460
LQZDevice, Jaw RepositioningClass II21 CFR 872.5570270
LRAHearing Aid, TactileUnclassified80
LRBFace Plate Hearing AidClass I21 CFR 874.3300240
LRCInstrument, Ent Manual SurgicalClass I21 CFR 874.4420655
LRDApplicator, Ent DrugClass I21 CFR 874.522061
LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, SterileClass I21 CFR 874.354000
LRFCandida Spp., Direct Antigen, IdClass II21 CFR 866.316532
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsClass II21 CFR 866.16404513
LRHInstrument For Auto Reader Of Overnight Microorganism Identification SystemClass I21 CFR 866.266040
LRIPh Meter For Dialysis Hydrogen Ion ConcentrationClass II21 CFR 876.582010
LRJDisinfectant, Medical DevicesClass I21 CFR 880.68907317
LRKDevice, Anti-SnoringClass II21 CFR 872.557021510
LRLCushion, HemorrhoidUnclassified30
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlClass II21 CFR 866.5100293
LRNWire, SurgicalClass II21 CFR 888.303081
LROGeneral Surgery TrayClass II21 CFR 878.43701101,070
LRPTray, SurgicalClass I21 CFR 878.480022109
LRQTracheostomy And Nasal Suctioning KitClass I64
LRRFirst Aid Kit With DrugNot classified1530
LRSI.V. Start KitClass II21 CFR 880.520030165
LRTIndicator, SterilizationClass II21 CFR 880.280051
LRWScissors, General, SurgicalClass I21 CFR 878.48001820
LRXCase, Contact LensClass II21 CFR 886.5928820
LRYPunch, SurgicalClass I21 CFR 878.480076
LRZScrewdriver, SurgicalClass I21 CFR 878.480036
LSAVise, Bench, SurgicalClass I21 CFR 878.480010
LSBUnit, FluidotherapyClass II21 CFR 890.510040
LSCNeisseria ControlsClass I21 CFR 866.266070
LSDRubella, Other AssaysClass II21 CFR 866.351000
LSEEpstein-Barr Virus, OtherClass I21 CFR 866.3235567
LSFDna-Reagents, Epstein-Barr VirusClass I21 CFR 866.323500
LSGCandida Species, Antibody DetectionClass II21 CFR 866.316500
LSHAntigen, Blastomyces Dermatitidis, OtherClass II21 CFR 866.306000
LSIAntiserum, Blastomyces Dermatitidis, OtherClass II21 CFR 866.306001
LSJAntigen, Rubella, OtherClass II21 CFR 866.351000
LSKDna-Reagents, ChlamydiaClass I21 CFR 866.312081
LSLDna-Reagents, NeisseriaClass II21 CFR 866.3390457
LSMDna-Reagents, Salmonella Spp.Class II21 CFR 866.355001
LSNDna-Reagents, Shigella Spp.Class II21 CFR 866.366000
LSODna-Reagents, CytomegalovirusClass II21 CFR 866.317501
LSQReagent, Rickettsia SerologicalClass I21 CFR 866.350040
LSRReagent, Borrelia Serological ReagentClass II21 CFR 866.38301125
LSWAnti-Dna Antibody, Antigen And ControlClass II21 CFR 866.510081
LSXController, Closed-Loop, Blood-PressureClass III00
LSYUltrasound, Hyperthermia, Cancer TreatmentClass III00
LSZVentilator, High FrequencyClass III07
LTAFluid, HysteroscopyClass III00
LTBCyclosporine RadioimmunoassayClass II21 CFR 862.123510
LTCHyaline Membrane Disease AssayClass III10
LTDParaquat AssayClass III21
LTFStimulator, Salivary SystemClass II21 CFR 872.5560235
LTGPaste, Injectable For Vocal Cord AugmentationClass III00
LTIImplant, Intragastric For Morbid ObesityClass III026
LTJProstate-Specific Antigen (Psa) For Management Of Prostate CancersClass II21 CFR 866.60103412
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)Class II21 CFR 866.6010268