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 34 of 71

FDA product codes, page 34 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
KJP	Carmine	Class I	21 CFR 864.1850	0	0
KJQ	Chlorazol Black E	Class I	21 CFR 864.1850	0	0
KJR	Erythrosin B	Class I	21 CFR 864.1850	3	0
KJS	Ethyl Eosin	Class I	21 CFR 864.1850	0	0
KJT	Indigocarmine	Class I	21 CFR 864.1850	0	0
KJW	Janus Green B	Class I	21 CFR 864.1850	0	0
KJX	Jenner Stain	Class I	21 CFR 864.1850	1	0
KJY	Malachite Green	Class I	21 CFR 864.1850	1	0
KJZ	Martius Yellow	Class I	21 CFR 864.1850	0	0
KKA	Methyl Orange	Class I	21 CFR 864.1850	0	0
KKB	Methyl Violet 2b	Class I	21 CFR 864.1850	0	0
KKC	Methylene Violet	Class I	21 CFR 864.1850	0	0
KKD	Nigrosin	Class I	21 CFR 864.1850	0	0
KKE	Orange Ii	Class I	21 CFR 864.1850	0	0
KKF	Orcein	Class I	21 CFR 864.1850	0	0
KKG	Protargol S	Class I	21 CFR 864.1850	0	0
KKH	Tablet, Resazurin	Class I	21 CFR 864.1850	0	1
KKI	Rose Bengal	Class I	21 CFR 864.1850	0	0
KKJ	Sudan Iii	Class I	21 CFR 864.1850	1	0
KKK	Sudan Iv	Class I	21 CFR 864.1850	1	2
KKL	Thionin	Class I	21 CFR 864.1850	0	0
KKM	Methylene Blue Thiocyanate	Class I	21 CFR 864.1850	0	0
KKO	Ring, Teething, Fluid-Filled	Class II	21 CFR 872.5550	27	9
KKP	Solution, Silver Carbonate	Class I	21 CFR 864.1850	0	0
KKQ	Sodium Periodate	Class I	21 CFR 864.1850	0	0
KKR	Potassium Periodate	Class I	21 CFR 864.1850	0	0
KKS	Acid, Periodic	Class I	21 CFR 864.1850	0	1
KKT	Hematoxylin, Ehrlich'S	Class I	21 CFR 864.1850	0	0
KKW	Basic Fuchsin	Class I	21 CFR 864.1850	0	0
KKX	Drape, Surgical, Antimicrobial	Class II	21 CFR 878.4370	450	91
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	Class II	21 CFR 878.3500	25	9
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Class II	21 CFR 876.1725	31	1
KLB	Radioimmunoassay, Tobramycin	Class II	21 CFR 862.3900	23	2
KLC	Chair, Dental, With Operative Unit	Class I	21 CFR 872.6250	63	7
KLE	Agent, Tooth Bonding, Resin	Class II	21 CFR 872.3200	420	20
KLH	Antisera, C. Acnes	Class I	21 CFR 866.3140	1	0
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Class II	21 CFR 862.1700	86	12
KLJ	Nad Reduction (U.V.), Phosphohexose Isomerase	Class I	21 CFR 862.1570	1	0
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Class II	21 CFR 868.2500	47	3
KLN	Radioimmunoassay, Cocaine Metabolite	Class II	21 CFR 862.3250	14	0
KLO	Enzymatic Radiochemical Assay, Gentamicin	Class II	21 CFR 862.3450	0	0
KLP	Amikacin Serum Assay	Class II	21 CFR 862.3035	4	0
KLQ	Radioimmunoassay, Amikacin	Class II	21 CFR 862.3035	20	0
KLR	Enzyme Immunoassay, Lidocaine	Class II	21 CFR 862.3555	17	1
KLS	Enzyme Immunoassay, Theophylline	Class II	21 CFR 862.3880	71	8
KLT	Enzyme Immunoassay, Carbamazepine	Class II	21 CFR 862.3645	56	5
KLW	Masker, Tinnitus	Class II	21 CFR 874.3400	78	0
KLX	Electroglottograph	Class II	21 CFR 874.1325	4	0
KLZ	Tube, Shunt, Endolymphatic With Valve	Class II	21 CFR 874.3850	1	0
KMA	Irrigator, Powered Nasal	Class I	21 CFR 874.5550	5	1
KMB	Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented	Class II	21 CFR 888.3490	0	0
KMC	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class II	21 CFR 888.3340	3	1
KMD	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite	Class II	21 CFR 888.3100	0	0
KME	Bedding, Disposable, Medical	Class I	21 CFR 880.6060	65	2
KMF	Bandage, Liquid	Class I	21 CFR 880.5090	222	4
KMG	Purifier, Water, Ultraviolet, Medical	Class II	21 CFR 880.6710	9	0
KMH	Sterilizer, Dry Heat	Class II	21 CFR 880.6870	10	0
KMI	Monitor, Bed Patient	Class I	21 CFR 880.2400	31	32
KMJ	Lubricant, Patient	Class I	21 CFR 880.6375	49	17
KMK	Device, Intravascular Catheter Securement	Class I	21 CFR 880.5210	64	7
KMN	Chair And Table, Medical	Class I	21 CFR 880.6140	3	3
KMO	Binder, Elastic	Class I	21 CFR 880.5160	5	0
KMS	Phenolphthalein Colorimetry, Carbon-Dioxide	Class II	21 CFR 862.1160	5	0
KMT	Tray, Fluoride, Disposable	Class I	21 CFR 872.6870	8	0
KMW	Handpiece, Rotary Bone Cutting	Class II	21 CFR 872.4120	9	10
KMY	Positioner, Tooth, Preformed	Class I	21 CFR 872.5525	12	0
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Class II	21 CFR 884.4530	58	0
KNB	Instrument, Destructive, Fetal, Obstetric	Class II	21 CFR 884.4500	1	0
KNC	Table, Obstetric (And Accessories)	Class II	21 CFR 884.4900	26	12
KND	Heater, Perineal	Class II	21 CFR 884.5390	0	0
KNE	Set, Anesthesia, Obstetric	Class II	21 CFR 884.5100	2	0
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Class II	21 CFR 884.4160	45	5
KNG	Monitor, Ultrasonic, Fetal	Class II	21 CFR 884.2660	60	1
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Class III	21 CFR 884.5380	0	4
KNK	Acid, Uric, Uricase (Colorimetric)	Class I	21 CFR 862.1775	118	15
KNL	Board, Scooter, Prone	Class I	21 CFR 890.5370	5	0
KNM	Device, Pressure Applying	Class I	21 CFR 890.5765	2	0
KNN	Components, Wheelchair	Class I	21 CFR 890.3920	64	11
KNO	Accessories, Wheelchair	Class I	21 CFR 890.3910	35	2
KNP	Orthosis, Corrective Shoe	Class I	21 CFR 890.3475	7	0
KNQ	Dilator, Esophageal	Class II	21 CFR 876.5365	40	21
KNR	Adapter, A-V Shunt Or Fistula	Class II	21 CFR 876.5540	1	0
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Class II	21 CFR 876.4300	189	125
KNT	Tubes, Gastrointestinal (And Accessories)	Class II	21 CFR 876.5980	651	268
KNW	Instrument, Biopsy	Class II	21 CFR 876.1075	365	107
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Class II	21 CFR 876.5250	206	21
KNY	Accessories, Catheter, G-U	Class II	21 CFR 876.5130	65	3
KNZ	Accessories, A-V Shunt	Class II	21 CFR 876.5540	10	0
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Class I	21 CFR 876.4730	44	6
KOB	Catheter, Suprapubic (And Accessories)	Class II	21 CFR 876.5090	32	66
KOC	Accessories, Blood Circuit, Hemodialysis	Class II	21 CFR 876.5820	182	17
KOD	Catheter, Urological	Class II	21 CFR 876.5130	238	108
KOE	Dilator, Urethral	Class II	21 CFR 876.5520	27	3
KOH	Instrument, Manual, General Obstetric-Gynecologic	Class I	21 CFR 884.4520	15	2
KOI	Stimulator, Nerve, Peripheral, Electric	Class II	21 CFR 868.2775	29	1
KOJ	Airbrush	Class II	21 CFR 872.6080	48	1
KOK	Sterilizer, Endodontic Dry Heat	Class III	21 CFR 872.6730	0	0
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer	Class I	21 CFR 872.3410	2	0
KOM	Adhesive, Denture, Acacia And Karaya With Sodium Borate	Class I	21 CFR 872.3400	1	0
KON	Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)	Class III	21 CFR 872.3480	0	0