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 39 of 71

FDA product codes, page 39 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
LJH	System, Irrigation, Urological	Class II	21 CFR 876.5130	29	7
LJK	Antisera, If, Toxoplasma Gondii	Class II	21 CFR 866.3780	6	0
LJL	Detectors And Removers, Lice, (Including Combs)	Class I	21 CFR 880.5960	11	0
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Class II	21 CFR 866.5100	112	2
LJN	Antibody Igm, If, Epstein-Barr Virus	Class I	21 CFR 866.3235	23	0
LJO	Antigen, Iha, Cytomegalovirus	Class II	21 CFR 866.3175	12	0
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	Class I	21 CFR 866.3120	35	0
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class II	21 CFR 880.5970	302	332
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	Class II	21 CFR 880.5965	288	141
LJW	Tracheotome	Class I	21 CFR 874.4420	2	1
LJX	Test, Urine Leukocyte	Class I	21 CFR 864.7675	7	5
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Class I	21 CFR 866.3380	8	7
LJZ	Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.	Class I	21 CFR 866.3375	13	4
LKA	Culture Media, Antimicrobial Susceptibility Test	Class II	21 CFR 866.1700	5	5
LKB	Pad, Alcohol, Device Disinfectant	Unclassified		25	9
LKC	Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus	Class II	21 CFR 866.3305	0	2
LKD	Monitor, Carbon-Dioxide, Cutaneous	Class II	21 CFR 868.2480	17	23
LKF	Cannula, Manipulator/Injector, Uterine	Class II	21 CFR 884.4530	87	13
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Class II	21 CFR 882.5550	8	0
LKH	Antisera, Immunoperoxidase, Chlamydia Spp.	Class I	21 CFR 866.3120	8	6
LKI	Antisera, Fluorescent, Chlamydia Spp.	Class I	21 CFR 866.3120	6	0
LKJ	Antinuclear Antibody, Antigen, Control	Class II	21 CFR 866.5100	50	13
LKK	Pump, Infusion, Implanted, Programmable	Class III		0	132
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Class I	21 CFR 866.5420	11	0
LKM	Counter, Urine Particle	Class II	21 CFR 864.5200	15	6
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unclassified		27	12
LKO	Anti-Rnp Antibody, Antigen And Control	Class II	21 CFR 866.5100	23	1
LKP	Anti-Sm Antibody, Antigen And Control	Class II	21 CFR 866.5100	28	1
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Class II	21 CFR 866.3175	18	8
LKS	Device, Parasite Concentration	Class I	21 CFR 866.2900	13	0
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	Class I	21 CFR 866.3480	23	0
LKV	Enzyme Immunoassay, Fetal Fibronectin	Class III		0	7
LKW	Laser, Neurosurgical	Class III		5	0
LKX	Device, Thermal, Hemorrhoids	Unclassified		18	0
LKY	Device, External Penile Rigidity	Class II	21 CFR 876.5020	87	0
LKZ	Red-Cell Count By Photometry	Class II	21 CFR 864.7100	2	0
LLA	Direct Agglutination Test, Toxoplasma Gondii	Class II	21 CFR 866.3780	4	0
LLB	System, Blood, Extracorporeal And Accessories	Class II	21 CFR 876.5820	2	1
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	Class II	21 CFR 880.5965	4	6
LLE	Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease	Class III		2	0
LLF	Laser, Neurosurgical, Argon	Class III		4	0
LLG	Kit, Igg, Platelet Associated	Class II	21 CFR 864.5425	2	1
LLH	Reagents, Clostridium Difficile Toxin	Class I	21 CFR 866.2660	42	11
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	Class II	21 CFR 880.5100	2	19
LLK	Legging, Compression, Non-Inflatable	Class II	21 CFR 880.5780	4	1
LLL	Extractable Antinuclear Antibody, Antigen And Control	Class II	21 CFR 866.5100	182	4
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Class I	21 CFR 866.3235	27	1
LLN	Device, Vibration Threshold Measurement	Class I	21 CFR 882.1200	13	0
LLO	Laser, Neodymium:Yag, Pulmonary Surgery	Class II	21 CFR 874.4500	19	0
LLP	Laser For Pain Therapy	Class III		0	0
LLQ	Cap, Cervical, Contraceptive	Class III		0	0
LLW	Laser, Neodymium:Yag For Gynecologic Use	Class II	21 CFR 884.4550	1	0
LLX	Catheter, Sampling, Chorionic Villus	Class III		0	0
LLZ	System, Image Processing, Radiological	Class II	21 CFR 892.2050	2,292	560
LMA	Digitizer, Image, Radiological	Class II	21 CFR 892.2030	61	2
LMB	Device, Digital Image Storage, Radiological	Class I	21 CFR 892.2010	55	19
LMC	Camera, Multi Format, Radiological	Class II	21 CFR 892.2040	121	3
LMD	System, Digital Image Communications, Radiological	Class I	21 CFR 892.2020	142	12
LME	Monitor, Blood-Flow, Cerebral, Thermal Diffusion	Class III		1	0
LMF	Agent, Absorbable Hemostatic, Collagen Based	Class III	21 CFR 878.4490	0	27
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	Class III	21 CFR 878.4490	0	4
LMH	Implant, Dermal, For Aesthetic Use	Class III		0	7
LMI	Implant, Collagen For Non-Aesthetic Use	Class III		0	0
LML	Ligaments And Tendons, Synthetic	Class III		0	0
LMN	Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses	Class III		0	0
LMQ	Device, Peritoneal Access, Subcutaneous, Implanted	Class III		1	0
LMS	Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology	Class II	21 CFR 874.4490	2	0
LMW	Solution, Removal, Carries	Class III		0	0
LMY	Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions	Class III		0	0
LMZ	Applicator, Hyperthermia, Interstitial	Class III		0	0
LNB	Applicator, Hyperthermia, Deep Heating, Ultrasound	Class III		0	0
LNC	Applicator, Hyperthermia, Superficial, Rf/Microwave	Class III		0	0
LNH	System, Nuclear Magnetic Resonance Imaging	Class II	21 CFR 892.1000	1,107	723
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Class II	21 CFR 892.1000	10	17
LNJ	Analyzer, Chromosome, Automated	Class II	21 CFR 864.5260	11	0
LNK	Laser For Gastro-Urology Use	Class II	21 CFR 878.4810	60	0
LNL	Stimulator, Electrical For Sperm Collection	Unclassified		1	0
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Class III		0	3
LNQ	Intestinal Stimulator	Humanitarian device exemption		0	1
LNR	System, Photopheresis, Extracorporeal	Class III		0	10
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Class II	21 CFR 876.5990	56	1
LNW	Paper, Obstetric Ph	Class I	21 CFR 862.1550	4	2
LNY	Catheter, Percutaneous, Long Term, Intraspinal	Class III		0	1
LNZ	Changer, Tube, Endotracheal	Class II	21 CFR 868.5730	1	3
LOA	Device, Testicular Hypothermia	Class III		0	0
LOB	Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination	Class III		0	4
LOC	System, Rf/Microwave Hyperthermia, Cancer Treatment	Class III		0	0
LOD	Bone Cement	Class II	21 CFR 888.3027	72	36
LOE	Stimulator, Invasive Bone Growth	Class III		0	4
LOF	Stimulator, Bone Growth, Non-Invasive	Class II	21 CFR 890.5870	0	5
LOG	Catheter, Balloon For Retinal Reattachment	Class III		0	0
LOH	System, Identification, Contact Lens	Class III		0	0
LOI	Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary	Class III		1	0
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Class II	21 CFR 866.6010	17	7
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Class III		0	1
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Class II	21 CFR 866.3310	26	12
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Class II	21 CFR 866.3172	1	33
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Class II	21 CFR 866.1645	289	238
LOO	Reagent, Leishmanii Serological	Class I	21 CFR 866.3870	2	0
LOP	Solution, Antimicrobial	Class II	21 CFR 866.1640	3	0