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 35 of 71

FDA product codes, page 35 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	Class I	21 CFR 872.3490	4	3
KOP	Adhesive, Denture, Karaya	Class I	21 CFR 872.3450	1	0
KOQ	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	Class I	21 CFR 872.3410	4	0
KOR	Adhesive, Denture, Karaya With Sodium Borate	Class III	21 CFR 872.3400	0	0
KOS	Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer	Class III	21 CFR 872.3420	0	0
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Class I	21 CFR 872.3490	8	0
KOX	Solvent, Adhesive Tape	Class I	21 CFR 878.4730	12	3
KOY	Degreaser, Skin, Surgical	Class I	21 CFR 878.4730	0	20
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	Class I	21 CFR 878.4018	22	0
KPA	Slide Stainer, Automated	Class I	21 CFR 864.3800	21	30
KPB	Media And Components, Mycoplasma Detection	Class I	21 CFR 864.2360	4	0
KPD	Strip, Temperature, Forehead, Liquid Crystal	Class II	21 CFR 880.2200	21	0
KPE	Container, I.V.	Class II	21 CFR 880.5025	117	62
KPF	System, Dialysate Delivery, Semi-Automatic, Peritoneal	Class II	21 CFR 876.5630	13	5
KPH	Catheter, Rectal For Continent Ileostomy	Class I	21 CFR 876.5030	1	0
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Class II	21 CFR 876.5320	97	0
KPJ	Chamber, Oxygen, Topical, Extremity	Class II	21 CFR 878.5650	23	2
KPK	Marker, Ostia, Aorto-Saphenous Vein	Class II	21 CFR 878.4650	6	0
KPL	Colonic Irrigation System	Class II	21 CFR 876.5220	40	2
KPM	Shunt, Peritoneal	Class II	21 CFR 876.5955	19	0
KPN	Alarm, Conditioned Response Enuresis	Class II	21 CFR 876.2040	37	4
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Class II	21 CFR 876.5820	124	113
KPP	Peritoneal Dialysate Filter	Class II	21 CFR 876.5630	3	0
KPQ	System, Simulation, Radiation Therapy	Class II	21 CFR 892.5840	70	13
KPR	System, X-Ray, Stationary	Class II	21 CFR 892.1680	359	168
KPS	System, Tomography, Computed, Emission	Class II	21 CFR 892.1200	473	449
KPT	Calibrator, Dose, Radionuclide	Class II	21 CFR 892.1360	32	4
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Class II	21 CFR 892.1610	16	0
KPX	Changer, Radiographic Film/Cassette	Class II	21 CFR 892.1860	26	0
KPY	Shield, Protective, Personnel	Class I	21 CFR 892.6500	25	2
KPZ	Generator, High Voltage, X-Ray, Therapeutic	Class II	21 CFR 892.5900	3	0
KQA	Device, Beam Limiting, X-Ray, Therapeutic	Class II	21 CFR 892.5900	4	0
KQC	Stains, Hematology	Class I	21 CFR 864.1850	9	5
KQE	Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase	Class II	21 CFR 864.7360	1	0
KQF	Assay, Glutathione Reductase	Class II	21 CFR 864.7375	0	0
KQG	Instrument, Coagulation	Class II	21 CFR 864.5400	14	1
KQH	Red-Cell Indices	Class II	21 CFR 864.5300	1	0
KQI	Assay, Fetal Hemoglobin	Class II	21 CFR 864.7455	4	0
KQJ	System, Fibrinogen Determination	Class II	21 CFR 864.7340	28	3
KQL	Tube, Tympanostomy With Semi-Permeable Membrane	Class II	21 CFR 874.3930	0	0
KQM	Camera, Surgical And Accessories	Class I	21 CFR 878.4160	18	14
KQN	Radioassay, Angiotensin Converting Enzyme	Class II	21 CFR 862.1090	8	0
KQO	Automated Urinalysis System	Class I	21 CFR 862.2900	46	33
KQP	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase	Class II	21 CFR 862.1315	7	1
KQQ	Tubing, Dialysate (And Connector)	Class II	21 CFR 876.5820	1	0
KQR	Detector, Air Or Foam	Class II	21 CFR 876.5820	0	0
KQS	Table, Cystometric, Non-Electric And Accessories	Class I	21 CFR 876.4890	8	0
KQT	Evacuator, Gastro-Urology	Class II	21 CFR 876.4370	14	12
KQW	Goniometer, Nonpowered	Class I	21 CFR 888.1520	13	0
KQX	Goniometer, Ac-Powered	Class I	21 CFR 888.1500	33	0
KQZ	Component, Traction, Non-Invasive	Class I	21 CFR 888.5890	11	9
KRA	Catheter, Continuous Flush	Class II	21 CFR 870.1210	177	96
KRB	Probe, Thermodilution	Class II	21 CFR 870.1915	37	4
KRC	Tester, Electrode, Surface, Electrocardiographic	Class II	21 CFR 870.2370	11	0
KRD	Device, Vascular, For Promoting Embolization	Class II	21 CFR 870.3300	132	20
KRE	Analyzer, Pacemaker Generator Function, Indirect	Class II	21 CFR 870.3640	13	0
KRF	Charger, Pacemaker	Class I	21 CFR 870.3670	0	0
KRG	Programmer, Pacemaker	Class III	21 CFR 870.3700	25	11
KRH	Ring, Annuloplasty	Class II	21 CFR 870.3800	75	0
KRI	Accessory Equipment, Cardiopulmonary Bypass	Class I	21 CFR 870.4200	42	8
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Class II	21 CFR 870.4280	24	0
KRK	Manometer, Blood-Pressure, Venous	Class II	21 CFR 870.1140	9	2
KRL	Detector, Bubble, Cardiopulmonary Bypass	Class II	21 CFR 870.4205	14	4
KRN	Metal Cemented Constrained Femorotibial Knee Prosthesis	Class III	21 CFR 888.3480	0	0
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	21 CFR 888.3510	87	124
KRP	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal	Class III	21 CFR 888.3550	0	1
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Class II	21 CFR 888.3550	0	1
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	21 CFR 888.3540	27	9
KRS	Prosthesis, Knee, Hemi-, Femoral (Uncemented)	Class III	21 CFR 888.3570	0	0
KRX	Calibrator For Cell Indices	Class II	21 CFR 864.8150	16	0
KRY	Calibrator For Platelet Counting	Class II	21 CFR 864.8175	8	1
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Class II	21 CFR 864.8165	25	2
KSA	Calibrator For Red-Cell And White-Cell Counting	Class II	21 CFR 864.8185	8	0
KSB	Set, Transfer (Blood/Plasma)	Class II	21 CFR 864.9875	6	11
KSD	Device, Heat-Sealing	Class I	21 CFR 864.9750	1	1
KSE	Refrigerator, Freezer, Blood Storage	Class II	21 CFR 864.9700	4	0
KSF	Kit, Quality Control For Blood Banking Reagents	Class II	21 CFR 864.9650	12	0
KSG	Media, Potentiating For In Vitro Diagnostic Use	Class II	21 CFR 864.9600	13	1
KSH	Chamber, Environmental For The Storage Of Platelet Concentrate	Class II	21 CFR 864.9575	0	0
KSI	Lectins And Protectins	Class II	21 CFR 864.9550	4	0
KSJ	System, Identification, Hepatitis B Antigen	Class III		0	0
KSK	Solution, Stabilized Enzyme	Class II	21 CFR 864.9400	5	0
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Class I	21 CFR 864.9320	2	0
KSM	System, Test, Combs, Automated	Class II	21 CFR 864.9300	0	0
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Class II	21 CFR 864.9285	1	0
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Class I	21 CFR 864.9275	1	0
KSP	Apparatus, Cell-Freezing And Reagents	Class I	21 CFR 864.9225	1	0
KSQ	Device, Blood Mixing And Blood Weighing	Class I	21 CFR 864.9195	8	0
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Class II	21 CFR 864.9100	16	4
KSS	Supplies, Blood-Bank	Class I	21 CFR 864.9050	6	0
KST	System, Blood Collection, Vacuum-Assisted, Manual	Class I	21 CFR 864.9125	0	4
KSW	System, Processing For Frozen Blood	Class II	21 CFR 864.9145	1	0
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use	Class II	21 CFR 864.9160	8	0
KSY	Boxes, View, Blood Grouping	Class I	21 CFR 864.9185	1	0
KSZ	System, Test, Automated Blood Grouping And Antibody	Class II	21 CFR 864.9175	4	0
KTA	Medium, Contrast, Radiologic	Unclassified		8	0
KTB	Device, Iontophoresis, Specific Uses	Class II	21 CFR 890.5525	16	0
KTC	Bath, Sitz, Nonpowered	Class I	21 CFR 890.5125	7	0
KTD	Orthosis, Abdominal	Class I	21 CFR 890.3490	3	0
KTE	Trocar, Ent	Class I	21 CFR 874.4420	1	0