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 2026-10-08, 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 36 of 71

FDA product codes, page 36 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
KTF	Punch, Ent	Class I	21 CFR 874.4420	0	0
KTG	Knife, Ent	Class I	21 CFR 874.4420	5	0
KTH	Device, Anti-Stammering	Class I	21 CFR 874.5840	4	0
KTI	Bronchoscope Accessory	Class II	21 CFR 874.4680	34	12
KTJ	System, Test, Alpha-Fetoprotein, Ria	Class III		0	0
KTK	Reagent, Immunoassay, Carbonic Anhydrase B And C	Class I	21 CFR 866.5200	0	0
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Class II	21 CFR 866.5100	19	0
KTM	C3-Indirect Immunofluorescent Solid Phase	Class II	21 CFR 866.5240	0	0
KTN	System, Test, Infectious Mononucleosis	Class II	21 CFR 866.5640	59	9
KTO	Reagent, Immunoassay, Igg	Class I	21 CFR 866.5530	2	2
KTP	Complement C3b Activator Immunoassay Reagents	Class II	21 CFR 866.5260	1	0
KTQ	Reagent, Complement	Class I	21 CFR 866.4100	6	0
KTR	Tube, Aspirating, Bronchoscope, Rigid	Class II	21 CFR 874.4680	4	0
KTS	Second Antibody (Species Specific Anti-Animal Gamma Globulin)	Class II	21 CFR 866.5510	4	0
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	21 CFR 888.3030	404	89
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Class II	21 CFR 888.3030	38	57
KTX	Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented	Class II	21 CFR 888.3490	0	0
KTZ	Caliper	Class I	21 CFR 888.4150	7	0
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class III	21 CFR 888.3330	114	203
KWB	Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal	Class III	21 CFR 888.3370	0	0
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Class II	21 CFR 888.3730	46	13
KWE	Prosthesis, Finger, Constrained, Metal, Uncemented	Class III	21 CFR 888.3200	0	0
KWF	Prosthesis, Finger, Polymer	Class II	21 CFR 888.3230	0	0
KWG	Prosthesis, Finger, Constrained, Metal/Polymer	Class III	21 CFR 888.3220	0	0
KWH	Prosthesis, Toe, Constrained, Polymer	Class II	21 CFR 888.3720	21	2
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	21 CFR 888.3170	34	30
KWJ	Prosthesis, Elbow, Hemi-, Humeral, Metal	Class III	21 CFR 888.3180	0	0
KWK	Appliance, Nail/Blade/Plate Combination, Single Component	Class II	21 CFR 888.3030	1	0
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	21 CFR 888.3360	108	51
KWM	Prosthesis, Wrist, Semi-Constrained	Class II	21 CFR 888.3800	6	0
KWN	Prosthesis, Wrist, Carpal Lunate	Class II	21 CFR 888.3750	5	0
KWO	Prosthesis, Wrist, Carpal Scaphoid	Class II	21 CFR 888.3760	1	0
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	21 CFR 888.3050	430	68
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	21 CFR 888.3060	668	214
KWR	Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented	Class III	21 CFR 888.3640	0	1
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	21 CFR 888.3660	191	153
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	21 CFR 888.3650	72	31
KWW	Radioimmunoassay, Cholyglycine, Bile Acids	Class II	21 CFR 862.1177	6	0
KWX	Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids	Class II	21 CFR 862.1187	2	0
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	21 CFR 888.3390	99	88
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	21 CFR 888.3310	34	20
KXA	Prosthesis, Hip, Femoral, Resurfacing	Class II	21 CFR 888.3400	23	16
KXB	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class III	21 CFR 888.3410	0	3
KXC	Prosthesis, Ankle, Cemented, Non-Constrained	Class III	21 CFR 888.3120	0	0
KXD	Prosthesis, Hip, Constrained, Metal	Class III	21 CFR 888.3300	0	0
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Class II	21 CFR 888.3810	16	3
KXF	Applicator, Absorbent Tipped, Non-Sterile	Class I	21 CFR 880.6025	21	2
KXG	Applicator, Absorbent Tipped, Sterile	Class I	21 CFR 880.6025	1	10
KXH	Cradle, Patient, Radiologic	Class I	21 CFR 892.1830	9	2
KXJ	Table, Radiologic	Class II	21 CFR 892.1980	31	27
KXK	Source, Brachytherapy, Radionuclide	Class II	21 CFR 892.5730	151	7
KXM	System Accessories, Extracorporeal	Class II	21 CFR 876.5820	4	0
KXN	Monitor, Cardiac, Fetal	Class II	21 CFR 884.2600	2	1
KXO	Monitor, Pressure, Intrauterine	Class II	21 CFR 884.2700	26	0
KXP	Stent, Vaginal	Class II	21 CFR 884.3900	4	0
KXQ	Vibrator For Therapeutic Use, Genital	Class II	21 CFR 884.5960	4	0
KXR	Applicator, Resin	Class I	21 CFR 872.3140	3	0
KXS	Radioimmunoassay, Methaqualone	Class II	21 CFR 862.3630	16	0
KXT	Enzyme Immunoassay, Digoxin	Class II	21 CFR 862.3320	85	7
KXW	Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer	Class I	21 CFR 872.3410	0	0
KXX	Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer	Class I	21 CFR 872.3450	1	0
KXY	Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce	Class III	21 CFR 872.3500	0	0
KXZ	System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)	Class III	21 CFR 884.2982	7	0
KYA	System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)	Class I	21 CFR 884.2982	5	0
KYB	Lens, Guide, Intraocular	Class I	21 CFR 886.4300	39	7
KYD	Strip, Schirmer	Class I	21 CFR 886.1800	3	0
KYE	Inserter/Remover Contact Lens	Class I	21 CFR 886.5420	12	0
KYF	Implant, Eye Valve	Class II	21 CFR 886.3920	25	6
KYG	Device, Irrigation, Ocular Surgery	Class I	21 CFR 886.4360	40	11
KYH	Endoscope, Ophthalmic	Class II	21 CFR 876.1500	1	0
KYI	Prosthesis, Wrist, Carpal Trapezium	Class II	21 CFR 888.3770	26	5
KYJ	Prosthesis, Finger, Constrained, Polymer	Class II	21 CFR 888.3230	14	4
KYK	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	Class II	21 CFR 888.3500	3	0
KYM	Metallic Cemented Glenoid Hemi-Shoulder Prosthesis	Class III	21 CFR 888.3680	0	0
KYN	Prosthesis, Wrist, Constrained, Metal	Class III	21 CFR 888.3790	0	0
KYP	Snake Bite Suction Kit	Class I	21 CFR 880.5740	4	0
KYQ	Kit, Chemical Snake-Bite	Class III	21 CFR 880.5760	0	0
KYR	Bag, Ice	Class I	21 CFR 880.6050	4	0
KYS	Insoles, Medical	Class I	21 CFR 880.6280	1	0
KYT	Light, Examination, Medical, Battery Powered	Class I	21 CFR 880.6350	6	1
KYW	Container, Liquid Medication, Graduated	Class I	21 CFR 880.6430	2	13
KYX	Dispenser, Liquid Medication	Class I	21 CFR 880.6430	11	17
KYZ	Syringe, Irrigating (Non Dental)	Class I	21 CFR 880.6960	41	20
KZA	Device, Vein Location, Liquid Crystal	Class I	21 CFR 880.6970	6	2
KZB	Automated Colony Counter	Class I	21 CFR 866.2170	1	2
KZC	Manual Colony Counter	Class I	21 CFR 866.2180	0	0
KZD	Infusor, Pressure, For I.V. Bags	Class I	21 CFR 880.5420	35	14
KZE	Injector, Fluid, Non-Electrically Powered	Class II	21 CFR 880.5430	53	1
KZF	Device, Medical Examination, Ac Powered	Class I	21 CFR 880.6320	37	5
KZH	Introducer, Syringe Needle	Class II	21 CFR 880.6920	47	10
KZI	Culture Media, Enriched	Class I	21 CFR 866.2330	51	2
KZJ	Device, Gas Generating	Class I	21 CFR 866.2580	18	4
KZK	Reader, Zone, Automated	Class I	21 CFR 866.2850	3	0
KZL	Device, Warming. Blood And Plasma	Class II	21 CFR 864.9205	4	0
KZM	Device, Muscle Monitoring	Class II	21 CFR 890.1375	19	0
KZN	Scanner, Color	Class II	21 CFR 872.3661	2	0
KZO	Ink, Arch Tracing	Class I	21 CFR 872.3150	2	0
KZP	Solution, Cement Dissolving	Class II	21 CFR 872.3750	2	1
KZQ	Chromatography(Gas), Clinical Use	Class I	21 CFR 862.2250	12	0
KZR	Chromatography (Liquid, Gel), Clinical Use	Class I	21 CFR 862.2260	15	0