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 21 of 71

FDA product codes, page 21 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Class II	21 CFR 884.4150	16	0
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Class I	21 CFR 884.1550	20	1
HIQ	Electrode, Clip, Fetal Scalp (And Applicator)	Class III	21 CFR 884.2685	0	0
HIR	Perineometer	Class II	21 CFR 884.1425	65	1
HIS	Condom	Class II	21 CFR 884.5300	402	7
HIT	Tester, Color Vision	Class I	21 CFR 886.1170	9	0
HIW	Anomaloscope	Class I	21 CFR 886.1070	3	0
HIX	Maxwell Spot, Ac-Powered	Class I	21 CFR 886.1435	2	0
HIY	Brush, Haidinger, (Including Macular Integrity)	Class I	21 CFR 886.1090	0	0
HJA	Photokeratoscope	Class I	21 CFR 886.1350	5	0
HJB	Instrument, Measuring, Corneal Radius	Class I	21 CFR 886.1450	5	2
HJC	Esthesiometer, Ocular	Class I	21 CFR 886.1040	2	0
HJD	Illuminator, Color Vision Plate	Class I	21 CFR 886.1160	1	0
HJE	Lamp, Fluorescein, Ac-Powered	Class II	21 CFR 878.4580	3	0
HJF	Magnifier, Hand-Held, Low-Vision	Class I	21 CFR 886.5540	1	0
HJG	System, Reading, Television, Closed-Circuit	Class I	21 CFR 886.5820	8	0
HJH	Loupe, Binocular, Low Power	Class I	21 CFR 886.5120	3	0
HJI	Lens, Fundus, Hruby, Diagnostic	Class I	21 CFR 886.1395	8	1
HJJ	Lens, Fresnel, Flexible, Diagnostic	Class I	21 CFR 886.1390	0	0
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Class II	21 CFR 886.1385	41	3
HJL	Lens, Condensing, Diagnostic	Class I	21 CFR 886.1380	1	1
HJM	Transilluminator, Ac-Powered	Class II	21 CFR 886.1945	12	3
HJN	Transilluminator, Battery-Powered	Class I	21 CFR 886.1945	3	1
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Class II	21 CFR 886.1850	109	8
HJQ	Stereoscope, Ac-Powered	Class I	21 CFR 886.1870	1	0
HJR	Stereoscope, Battery-Powered	Class I	21 CFR 886.1870	0	0
HJS	Test, Spectacle Dissociation, Ac-Powered (Lancaster)	Class I	21 CFR 886.1910	0	0
HJT	Haploscope	Class I	21 CFR 886.1340	2	0
HJW	Adaptometer (Biophotometer)	Class I	21 CFR 886.1050	0	0
HJX	Reader, Prism, Ophthalmic	Class I	21 CFR 886.5810	1	0
HJY	Reader, Bar, Ophthalmic	Class I	21 CFR 886.5800	1	0
HJZ	Crutch, Ptosis	Class I	21 CFR 886.5600	0	0
HKB	Telescope, Hand-Held, Low-Vision	Class I	21 CFR 886.5870	0	0
HKC	Spectacle Microscope, Low-Vision	Class I	21 CFR 886.5540	1	0
HKD	Tape, Nystagmus	Class I	21 CFR 886.1905	0	0
HKF	Mirror, Headband, Ophthalmic	Class I	21 CFR 886.1500	0	0
HKG	Fornixscope	Class I	21 CFR 886.1320	0	0
HKI	Camera, Ophthalmic, Ac-Powered	Class II	21 CFR 886.1120	157	9
HKK	Telescope, Spectacle, Low-Vision	Class I	21 CFR 886.5870	2	0
HKL	Retinoscope, Ac-Powered	Class II	21 CFR 886.1780	6	0
HKM	Retinoscope, Battery-Powered	Class I	21 CFR 886.1780	7	0
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Class I	21 CFR 886.1770	3	7
HKO	Refractometer, Ophthalmic	Class I	21 CFR 886.1760	35	5
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Class II	21 CFR 886.4150	16	0
HKQ	Prism, Rotary, Ophthalmic	Class I	21 CFR 886.1665	0	0
HKR	Lens, Maddox	Class I	21 CFR 886.1400	0	0
HKS	Prism, Gonioscopic	Class I	21 CFR 886.1660	10	1
HKT	Prism, Fresnel, Ophthalmic	Class I	21 CFR 886.1655	0	0
HKW	Prism, Bar, Ophthalmic	Class I	21 CFR 886.1650	2	0
HKX	Tonometer, Ac-Powered	Class II	21 CFR 886.1930	58	0
HKY	Tonometer, Manual	Class II	21 CFR 886.1930	56	2
HKZ	Sterilizer, Tonometer	Class I	21 CFR 886.1940	0	0
HLA	Calibrator, Tonometer	Class II	21 CFR 886.1930	0	0
HLC	Instrument, Measuring, Stereopsis	Class I	21 CFR 886.1460	0	0
HLD	Engine, Trephine, Accessories, Gas-Powered	Class I	21 CFR 886.4070	0	0
HLE	Ruler, Nearpoint (Punctometer)	Class I	21 CFR 886.1790	0	0
HLF	Device, Measuring, Lens Radius, Ophthalmic	Class I	21 CFR 886.1430	3	1
HLG	Pupillometer, Ac-Powered	Class I	21 CFR 886.1700	3	0
HLH	Pupillometer, Manual	Class I	21 CFR 886.1700	2	0
HLI	Ophthalmoscope, Ac-Powered	Class II	21 CFR 886.1570	87	7
HLJ	Ophthalmoscope, Battery-Powered	Class II	21 CFR 886.1570	47	0
HLK	Screen, Tangent, Target, Battery-Powered	Class I	21 CFR 886.1810	0	0
HLL	Monitor, Eye Movement	Class II	21 CFR 886.1510	4	0
HLM	Instrument, Measuring, Lens, Ac-Powered	Class I	21 CFR 886.1425	16	1
HLN	Gauge, Lens, Ophthalmic	Class I	21 CFR 886.1420	2	0
HLO	Test, Spectacle Dissociation, Battery-Powered (Lancaster)	Class I	21 CFR 886.1910	0	0
HLP	Target, Fusion And Stereoscopic	Class I	21 CFR 886.1880	3	0
HLQ	Keratoscope, Ac-Powered	Class I	21 CFR 886.1350	29	0
HLR	Keratoscope, Battery-Powered	Class I	21 CFR 886.1350	7	0
HLS	Exophthalmometer	Class I	21 CFR 886.1270	1	0
HLT	Preamplifier, Ac-Powered, Ophthalmic	Class II	21 CFR 886.1640	4	0
HLW	Preamplifier, Battery-Powered, Ophthalmic	Class II	21 CFR 886.1640	3	0
HLX	Photostimulator, Ac-Powered	Class II	21 CFR 886.1630	18	0
HLZ	Electrode, Corneal	Class II	21 CFR 886.1220	11	0
HMC	Monitor, Eye Movement, Diagnostic	Class II	21 CFR 886.1510	1	0
HMD	Chair, Ophthalmic, Manual	Class I	21 CFR 886.1140	1	0
HME	Chair, Ophthalmic, Ac-Powered	Class I	21 CFR 886.1140	16	1
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Class I	21 CFR 886.1860	15	0
HMG	Stand, Instrument, Ophthalmic, Non-Powered	Class I	21 CFR 886.1860	4	0
HMH	Rack, Skiascopic	Class I	21 CFR 886.1750	2	0
HMJ	Screen, Tangent, Projection, Battery-Powered	Class I	21 CFR 886.1810	2	0
HMK	Euthyscope, Ac-Powered	Class II	21 CFR 886.1250	0	0
HML	Euthyscope, Battery-Powered	Class I	21 CFR 886.1250	0	0
HMM	Distometer	Class I	21 CFR 886.1190	2	0
HMN	Suture, Nonabsorable, Ophthalmic	Class III		1	0
HMO	Suture, Absorbable, Ophthalmic	Class III		0	0
HMP	Pad, Eye	Class I	21 CFR 878.4440	17	4
HMQ	Marker, Sclera	Class I	21 CFR 886.4570	0	1
HMR	Marker, Ocular	Class I	21 CFR 886.4570	5	6
HMS	Drum, Eye Knife Test	Class I	21 CFR 886.4230	1	0
HMT	Drape, Patient, Ophthalmic	Class II	21 CFR 878.4370	7	1
HMW	Drape, Microscope, Ophthalmic	Class II	21 CFR 878.4370	4	0
HMX	Cannula, Ophthalmic	Class I	21 CFR 886.4350	77	28
HMY	Keratome, Battery-Powered	Class I	21 CFR 886.4370	12	2
HMZ	Trabeculotome	Class I	21 CFR 886.4350	0	1
HNA	Spud, Ophthalmic	Class I	21 CFR 886.4350	2	0
HNB	Spoon, Ophthalmic	Class I	21 CFR 886.4350	0	0
HNC	Specula, Ophthalmic	Class I	21 CFR 886.4350	11	1
HND	Spatula, Ophthalmic	Class I	21 CFR 886.4350	6	0
HNE	Snare, Enucleating	Class I	21 CFR 886.4350	0	0