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 2026-10-05, 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 panel	Panel code	Product codes
Anesthesiology	AN	262
Cardiovascular	CV	437
Clinical Chemistry	CH	527
Clinical Toxicology	TX	338
Dental	DE	352
Ear, Nose, Throat	EN	269
Gastroenterology, Urology	GU	614
General Hospital	HO	394
General, Plastic Surgery	SU	562
Hematology	HE	281
Immunology	IM	278
Medical Genetics	MG	7
Microbiology	MI	554
Neurology	NE	291
Obstetrics/Gynecology	OB	269
Ophthalmic	OP	345
Orthopedic	OR	349
Pathology	PA	325
Physical Medicine	PM	210
Radiology	RA	216

214 codes carry no review panel in the FDA classification file and appear only in the index below

7,094 product codes, page 38 of 71

FDA product codes, page 38 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
LEQ	Detectors, Electrochemical, Liquid Chromatography	Class I	21 CFR 862.2260	4	0
LER	Fluorescent Immunoassay, Theophylline	Class II	21 CFR 862.3880	15	1
LES	Fluorescent Immunoassay, Diphenylhydantoin	Class II	21 CFR 862.3350	7	0
LET	Fluorescent Immunoassay, Phenobarbital	Class II	21 CFR 862.3660	8	0
LEW	Thin Layer Chromatography, Theophylline	Class II	21 CFR 862.3880	1	0
LEY	Set, Oral Administration	Class II	21 CFR 876.5980	1	0
LEZ	Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)	Unclassified		3	1
LFA	Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)	Unclassified		2	0
LFB	Button, Nasal Septal	Unclassified		12	2
LFC	Device, Caries Detection	Class II	21 CFR 872.1740	17	0
LFD	Saliva, Artificial	Unclassified		50	6
LFE	Solution, Cold Sterilizing	Class II	21 CFR 880.6885	1	0
LFF	Unit, Activation, Breath Control	Class I	21 CFR 890.3920	1	0
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Class II	21 CFR 862.3910	21	2
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Class II	21 CFR 862.3910	6	3
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Class II	21 CFR 862.3910	4	0
LFJ	Catheter, Subclavian	Class II	21 CFR 876.5540	65	6
LFK	Catheter, Femoral	Class II	21 CFR 876.5540	16	7
LFL	Instrument, Ultrasonic Surgical	Unclassified		158	109
LFM	Enzyme Immunoassay, Digitoxin	Class II	21 CFR 862.3300	20	5
LFN	Nephelometric Inhibition Immunoassay, Phenobarbital	Class II	21 CFR 862.3660	5	0
LFO	Nephelometric Inhibition Immunoassay, Diphenylhydantoin	Class II	21 CFR 862.3350	1	0
LFP	Conductivity Rate, Urea Nitrogen	Class II	21 CFR 862.1770	6	0
LFQ	Acid, Uric, Acid Reduction Of Ferric Ion	Class I	21 CFR 862.1775	5	1
LFR	Glucose Dehydrogenase, Glucose	Class II	21 CFR 862.1345	73	51
LFS	Radioreceptor Assay, Human Chorionic Gonadotropin	Class II	21 CFR 862.1155	0	0
LFT	Fluorescent Immunoassay, Primidone	Class II	21 CFR 862.3680	8	0
LFW	Fluorescence Polarization Immunoassay, Tobramycin	Class II	21 CFR 862.3900	10	2
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Class II	21 CFR 866.3510	94	15
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Class II	21 CFR 866.3900	17	4
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Class II	21 CFR 866.3175	58	9
LGA	Device, Oxidase Test For Gonorrhea	Class III	21 CFR 866.2420	0	0
LGB	Gonococcal Antibody Tests	Class III	21 CFR 866.3290	0	1
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Class II	21 CFR 866.3305	38	7
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Class II	21 CFR 866.3780	106	7
LGE	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing	Class II	21 CFR 888.3530	2	1
LGF	Component, Cast	Class I	21 CFR 888.5940	31	0
LGG	Instrument, Cast Application/Removal, Manual	Class I	21 CFR 888.5980	3	0
LGH	Instrument, Cast Removal, Ac-Powered	Class I	21 CFR 888.5960	9	0
LGI	Fluorescence Polarization Immunoassay, Carbamazepine	Class II	21 CFR 862.3645	3	4
LGJ	Fluorescence Polarization Immunoassay, Amibacin	Class II	21 CFR 862.3035	3	0
LGL	Assay, Bart'S, Hemoglobin	Class II	21 CFR 864.7500	2	0
LGM	Chamber, Patient Isolation	Class II	21 CFR 880.5450	12	1
LGN	Chamber, Patient Transport Isolation	Class II	21 CFR 880.5450	2	0
LGO	Test, Leukocyte Typing	Class I	21 CFR 864.7675	5	0
LGP	Assay, Alpha-2-Antiplasmin	Class II	21 CFR 864.5425	5	0
LGQ	Fluorescence Polarization Immunoassay, Phenobarbital	Class II	21 CFR 862.3660	12	2
LGR	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	Class II	21 CFR 862.3350	15	0
LGS	Fluorescence Polarization Immunoassay, Theophylline	Class II	21 CFR 862.3880	13	0
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Class III		0	96
LGX	Table, Examination, Medical, Powered	Class I	21 CFR 878.4960	14	15
LGY	Trypan Blue	Class I	21 CFR 864.1850	1	0
LGZ	Warmer, Thermal, Infusion Fluid	Class II	21 CFR 880.5725	76	33
LHB	Timer, Apgar	Class I	21 CFR 880.2930	2	0
LHC	Warmer, Irrigation Solution	Class I	21 CFR 890.5950	24	10
LHD	Device, Fertility Diagnostic, Proceptive	Unclassified		24	0
LHE	Controller, Closed-Loop Blood Glucose	Class III		0	0
LHF	Warmer, Microwave, Infusion Fluid	Class II	21 CFR 880.5725	2	0
LHG	Electrode, Spinal Epidural	Class II	21 CFR 882.5880	1	0
LHI	Set, I.V. Fluid Transfer	Class II	21 CFR 880.5440	206	62
LHJ	Staphylococcus Aureus Protein A Insoluble	Class I	21 CFR 866.3700	3	2
LHK	Antigen, Id, Candida Albicans	Class II	21 CFR 866.3165	4	1
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Class II	21 CFR 866.3300	18	3
LHM	System, Thermographic, Liquid Crystal	Class I	21 CFR 884.2982	1	0
LHN	System, Radiation Therapy, Charged-Particle, Medical	Class II	21 CFR 892.5050	93	58
LHO	Instrument, Quality-Assurance, Radiologic	Class I	21 CFR 892.1940	8	2
LHP	System, Telethermographic (Sole Diagnostic Screen)	Class III	21 CFR 884.2980	0	0
LHQ	System, Telethermographic (Adjunctive Use)	Class I	21 CFR 884.2980	41	1
LHR	System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)	Class III	21 CFR 884.2982	0	0
LHT	Staphylococcus Aureus Somatic Antigens	Class I	21 CFR 866.3700	13	0
LHW	Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment	Class I	21 CFR 866.3720	4	0
LHX	Trousers, Anti-Shock	Class II	21 CFR 870.5800	4	1
LHY	Electrode, Stabilized Epidural Spinal	Class III		0	0
LHZ	Viscometer, Mucus, Cervical	Class I	21 CFR 884.1040	1	0
LIA	Antigens, All Groups, Shigella Spp.	Class II	21 CFR 866.3660	1	1
LIB	Device, General Purpose, Microbiology, Diagnostic	Class I	21 CFR 866.2660	43	13
LIC	Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae	Class II	21 CFR 866.3390	9	0
LIE	Reagent/Device, Inoculum Calibration	Class II	21 CFR 866.1640	7	2
LIF	Dialyzer Reprocessing System	Class II	21 CFR 876.5820	57	1
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Class II	21 CFR 862.1810	8	3
LIH	Interferential Current Therapy	Class II	21 CFR 882.5890	73	0
LII	Monitor, Intracranial Pressure, Implanted	Class III		0	0
LIJ	Peroxidase Anti-Peroxidase Immunohistochemical Stain	Class I	21 CFR 864.4400	2	0
LIL	Monitor, Penile Tumescence	Unclassified		26	0
LIM	Test, Screening, For D Positive Fetal Rbc'S	Class II	21 CFR 864.7455	2	0
LIN	Antisera, Conjugated Fluorescent, Cytomegalovirus	Class II	21 CFR 866.3175	17	0
LIO	Device, Specimen Collection	Class I	21 CFR 866.2900	63	3
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Class II	21 CFR 866.3830	35	18
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	Class I	21 CFR 866.3405	33	2
LIR	Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae	Class II	21 CFR 866.3390	3	0
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Class II	21 CFR 870.1250	405	32
LIW	Fibrillator, Ac	Unclassified		0	0
LIX	Aid, Cardiopulmonary Resuscitation	Class II	21 CFR 870.5210	17	2
LIZ	Assay, T Lymphocyte Surface Marker	Class II	21 CFR 864.5220	7	1
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Class I	21 CFR 866.3520	11	7
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	Class I	21 CFR 866.3120	67	7
LJD	Assay, B Lymphocyte Marker	Class II	21 CFR 864.5220	1	0
LJE	Catheter, Nephrostomy	Unclassified		56	12
LJF	Device, Antimicrobial Drug Removal	Class I	21 CFR 866.2560	4	0
LJG	Quality Control Slides	Class I	21 CFR 866.2660	27	5