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 37 of 71

FDA product codes, page 37 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
KZS	Chromatography (Thin Layer), Clinical Use	Class I	21 CFR 862.2270	0	0
KZT	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin	Class II	21 CFR 862.3450	1	0
KZW	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin	Class II	21 CFR 862.3520	0	0
KZX	Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin	Class II	21 CFR 862.3900	0	0
KZY	High Pressure Liquid Chromatography, Barbiturate	Class II	21 CFR 862.3150	0	0
KZZ	Gas Chromatography, Benzodiazepine	Class II	21 CFR 862.3170	0	0
LAA	High Pressure Liquid Chromatography, Benzodiazepine	Class II	21 CFR 862.3170	1	0
LAB	Thin Layer Chromatography, Benzodiazepine	Class II	21 CFR 862.3170	0	0
LAC	High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites	Class II	21 CFR 862.3250	0	0
LAD	Gas Chromatography, Codeine	Class II	21 CFR 862.3270	0	0
LAE	High Pressure Liquid Chromatography, Codeine	Class II	21 CFR 862.3270	2	0
LAF	Gas Chromatography, Methamphetamine	Class II	21 CFR 862.3610	49	1
LAG	High Pressure Liquid Chromatography, Methamphetamine	Class II	21 CFR 862.3610	4	0
LAH	High Pressure Liquid Chromatography, Opiates	Class II	21 CFR 862.3650	0	0
LAI	Thin Layer Chromatography, Opiates	Class II	21 CFR 862.3650	1	0
LAJ	Gas Chromatography, Propoxyphene	Class II	21 CFR 862.3700	0	0
LAK	High Pressure Liquid Chromatography, Propoxyphene	Class II	21 CFR 862.3700	0	0
LAL	Eas Chromatography, Quinine	Class I	21 CFR 862.3750	0	0
LAM	High Pressure Liquid Chromatography, Quinine	Class I	21 CFR 862.3750	0	0
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Class II	21 CFR 862.3320	21	1
LAO	Enzyme Immunoassay, Methotrexate	Unclassified		10	2
LAR	Enzyme Immunoassay, Procainamide	Class II	21 CFR 862.3320	25	0
LAS	Drug Specific Control Materials	Class I	21 CFR 862.3280	83	1
LAT	Radioimmunoassay, Cannabinoid(S)	Class II	21 CFR 862.3870	16	0
LAW	Theophylline Control Materials	Class I	21 CFR 862.3280	4	0
LAX	Lidocaine Control Materials	Class I	21 CFR 862.3280	1	0
LAY	Methotrexate Control Materials	Class I	21 CFR 862.3280	0	0
LAZ	N-Acetylprocainamide Control Materials	Class I	21 CFR 862.3280	4	1
LBA	Procainamide Control Materials	Class I	21 CFR 862.3280	1	0
LBB	Dynamometer, Ac-Powered	Class II	21 CFR 888.1240	36	2
LBC	Prosthesis, Finger, Constrained, Metal, Cemented	Class III	21 CFR 888.3210	0	0
LBE	Stroller, Adaptive	Class I	21 CFR 890.3850	8	0
LBG	Device, Fluidized Therapy, Dry Heat	Class II	21 CFR 890.5500	1	0
LBH	Varnish, Cavity	Class II	21 CFR 872.3260	139	9
LBI	Unit, Neonatal Phototherapy	Class II	21 CFR 880.5700	71	14
LBJ	Device, Vein Stabilization	Class I	21 CFR 880.6980	0	6
LBK	Neurosurgical Ultrasonic Instruments	Unclassified		7	1
LBL	Tube, Tympanostomy, Porous Polyethylene	Class II	21 CFR 874.3880	1	0
LBM	Porous Polyethylene Ossicular Replacement	Class II	21 CFR 874.3450	2	0
LBN	Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene	Class II	21 CFR 874.3495	1	0
LBP	Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material	Class II	21 CFR 874.3450	0	0
LBR	Ldl & Vldl Precipitation, Hdl	Class I	21 CFR 862.1475	66	11
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Class I	21 CFR 862.1475	80	9
LBT	Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl	Class I	21 CFR 862.1475	8	0
LBW	Set, Dialysis, Single Needle (Co-Axial Flow)	Class II	21 CFR 876.5540	5	0
LBX	Pelvimeter, Internal	Class II	21 CFR 884.4530	1	0
LBZ	Enzyme Immunoassay, Quinidine	Class II	21 CFR 862.3320	27	2
LCA	Radioimmunoassay, Theophylline	Class II	21 CFR 862.3880	5	0
LCC	Applicator, Ocular Pressure	Class II	21 CFR 886.4610	6	0
LCD	Enzyme Immunoassay, Gentamicin	Class II	21 CFR 862.3450	37	13
LCE	Radioimmunoassay, Netilmicin (I-125)	Class II	21 CFR 862.3450	6	0
LCG	Intestinal Splinting Tubes	Class II	21 CFR 876.5980	0	0
LCH	Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical	Class I	21 CFR 862.1660	9	2
LCI	Automated Radioimmunoassay Systems, For Clinical Use	Class I	21 CFR 862.2050	3	1
LCJ	Tissue Expander And Accessories	Unclassified		55	21
LCL	Radioimmunoassay, Phencyclidine	Unclassified		11	0
LCM	Enzyme Immunoassay, Phencyclidine	Unclassified		88	1
LCN	Scraper, Tongue	Class I	21 CFR 872.6855	31	0
LCO	Platelet Factor 4 Radioimmunoassay	Class II	21 CFR 864.7695	13	11
LCP	Assay, Glycosylated Hemoglobin	Class II	21 CFR 864.7470	249	103
LCQ	Fluorescent Immunoassay Gentamicin	Class II	21 CFR 862.3450	19	3
LCR	Fluorescent Immunoassay, Tobramycin	Class II	21 CFR 862.3900	17	0
LCS	Radioimmunoassay, Digoxin (125-I)	Class II	21 CFR 862.3320	15	0
LCT	Radioimmunoassay, Digoxin (3-H)	Class II	21 CFR 862.3320	0	0
LCW	Radioimmunoassay, Digitoxin (125-I)	Class II	21 CFR 862.3300	3	0
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Class II	21 CFR 862.1155	226	25
LCY	U.V. Spectrometry, Theophylline	Class II	21 CFR 862.3880	3	0
LCZ	U.V. Spectrometry, Primidone	Class II	21 CFR 862.3680	0	0
LDA	U.V. Spectrometry, Phenobarbital	Class II	21 CFR 862.3660	0	0
LDB	U.V. Spectrometry, Carbamazepine	Class II	21 CFR 862.3645	0	0
LDC	U.V. Spectrometry, Diphenylhydantoin	Class II	21 CFR 862.3350	0	0
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Class II	21 CFR 870.5300	166	31
LDE	Stethoscope, Manual	Class I	21 CFR 870.1875	28	0
LDF	Electrode, Pacemaker, Temporary	Class II	21 CFR 870.3680	130	15
LDG	Kit, Earmold, Impression	Class I	21 CFR 874.3300	2	0
LDJ	Enzyme Immunoassay, Cannabinoids	Class II	21 CFR 862.3870	150	15
LDK	Device, Sensing, Optical Contour	Unclassified		8	0
LDM	Instrumentation, High Pressure Liquid Chromatography	Class I	21 CFR 862.2260	19	1
LDN	Enzymatic Radiochemical Assay, Amikacin	Class II	21 CFR 862.3035	3	0
LDO	Enzymatic Radiochemical Assay, Tobramycin	Class II	21 CFR 862.3900	3	0
LDP	Colorimetry, Acetaminophen	Class II	21 CFR 862.3030	37	12
LDR	Controller, Infusion, Intravascular, Electronic	Class II	21 CFR 880.5725	60	5
LDS	Device, Pasteurization, Hot Water	Class II	21 CFR 880.6991	11	11
LDW	Fixative, Acid Containing	Class I	21 CFR 864.4010	4	0
LDX	Fixative, Metallic Containing	Class I	21 CFR 864.4010	1	0
LDY	Fixative, Formalin-Containing	Class I	21 CFR 864.4010	1	7
LDZ	Fixative, Alcohol Containing	Class I	21 CFR 864.4010	8	0
LEA	Preservative, Cytological	Class I	21 CFR 864.4010	4	4
LEB	Mounting Media	Class I	21 CFR 864.4010	5	0
LEC	Grinder, Tissue	Class I	21 CFR 864.3010	0	0
LED	Stains, Chemical Solution	Class I	21 CFR 864.1850	16	0
LEE	Stains, Dye Solution	Class I	21 CFR 864.1850	1	0
LEF	Stains, Dye Powder	Class I	21 CFR 864.1850	1	0
LEG	Enzyme Immunoassay, Valproic Acid	Class II	21 CFR 862.3645	35	7
LEH	Radioimmunoassay, Vancomycin	Class II	21 CFR 862.3950	31	12
LEI	Implant, Anti-Gastroesophageal Reflux	Class III		0	5
LEJ	Booth, Sun Tan	Class II	21 CFR 878.4635	81	6
LEK	Transilluminator (Diaphanoscope)	Class III	21 CFR 892.1990	0	1
LEL	Device, Sleep Assessment	Class II	21 CFR 882.5050	19	0
LEM	Human Lyophilized Dura Mater	Class II	21 CFR 882.5975	2	0