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 64 of 71

FDA product codes, page 64 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
QHA	X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device	Class II	21 CFR 892.1600	7	0
QHC	Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs	Class II	21 CFR 876.1075	0	0
QHE	Shoulder Arthroplasty Implantation System	Class II	21 CFR 888.3660	26	2
QHF	Energy Based Device For Treatment Of Tattoos	Class II	21 CFR 878.4810	0	0
QHG	Defect Measurement Tool	Class II	21 CFR 888.4510	1	0
QHH	Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)	Class II	21 CFR 876.5340	6	0
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use	Class III		0	1
QHM	Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations	Unclassified	21 CFR 610.40	0	0
QHO	Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations	Unclassified	21 CFR 610.40	0	0
QHP	Vertebral Body Tethering System	Not classified		0	0
QHQ	Total Shoulder Arthroplasty System	Class II	21 CFR 888.3660	1	1
QHR	Blood Grouping Reagent	Unclassified	21 CFR 660.20	0	1
QHS	Anti-Human Globulin	Unclassified	21 CFR 660.50	0	0
QHT	Reagent Red Blood Cells	Unclassified	21 CFR 660.30	0	0
QHV	Multiple Osteoarticular Pathogen Antigen Kit	Not classified		0	0
QHW	Single Lumen Ecmo Cannula	Class II	21 CFR 870.4100	3	0
QHX	Fluoroscopic X-Ray Image Intensifier	Class I	21 CFR 892.1960	0	0
QHY	Solid State Fluoroscopic X-Ray Imager	Class II	21 CFR 892.1650	0	0
QHZ	Seal, Cervical, Mechanical, Unpowered	Class I	21 CFR 884.1690	0	0
QIA	Powered Tongue Scraper	Class I	21 CFR 872.6865	1	0
QIC	Hiv-1 Genotyping Assay Using Ngs Technology	Class II	21 CFR 866.3955	0	0
QID	Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens	Class II	21 CFR 866.4002	1	0
QIG	Quality Control Material, Genetics, Rna	Class II	21 CFR 866.5910	0	0
QIH	Automated Radiological Image Processing Software	Class II	21 CFR 892.2050	334	2
QII	Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use	Class II	21 CFR 862.1355	1	0
QIJ	Endoscopic Transhepatic Venous Access Needle	Class II	21 CFR 876.1050	1	0
QIK	Organ Care System (Ocs) Heart System	Class III		0	0
QIM	Bartonella Spp. Serological Reagents	Not classified		0	0
QIN	Babesia Spp. Serological Reagents	Not classified		0	0
QIO	Anaplasma Spp. And Ehrlichia Spp. Serological Reagents	Not classified		0	0
QIP	Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents	Not classified		0	0
QIQ	Orientia Spp. (Scrub Typhus) Serological Reagents	Not classified		0	0
QIR	Pediatric Hemodialysis System	Class II	21 CFR 876.5861	1	0
QIS	Esophageal, Mucosal, Electrical Characterization	Class II	21 CFR 876.1450	3	0
QIT	Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia	Class III		0	0
QIU	Intense Pulsed Light Device For Managing Dry Eye	Class II	21 CFR 886.5201	1	0
QIV	Culture-Based Short-Term Incubation Antimicrobial Resistance Assay	Class II	21 CFR 866.1655	1	0
QIX	System, Transdermal Delivery, Cder Or Cber Led	Not classified		0	0
QIY	Nasal Spray, Systemic Delivery, Cder Or Cber Led	Not classified		0	0
QIZ	Material, Implantable For Controlled Release, Cder Or Cber Led	Not classified		0	0
QJA	Tympanostomy Tube Delivery Product With Drug	Class III		0	0
QJB	Adjunct Monitor, Protein Calorie Malnutrition	Class II	21 CFR 870.2770	2	0
QJC	Plaque Disclosing Agent	Class I	21 CFR 872.6855	1	0
QJD	Absorbable Metallic Bone Fixation Fastener	Class II	21 CFR 888.3041	1	0
QJE	Muscular Dystrophy Newborn Screening Test	Class II	21 CFR 862.1506	1	0
QJF	Autofluorescence Imaging Adjunct Tool For Wounds	Class II	21 CFR 878.4550	7	1
QJG	Device System, Imaging, Tympanic Membrane And Middle Ear	Class II	21 CFR 892.1560	2	0
QJH	Reverse Central Venous Recanalization System	Class II	21 CFR 870.1342	2	0
QJI	Interoperable Automated Glycemic Controller	Class II	21 CFR 862.1356	24	0
QJJ	Indirect Bonding Tray	Class I	21 CFR 872.5410	0	1
QJK	Intraoral Camera	Class II	21 CFR 872.3661	0	0
QJL	Splint, Intranasal Septal, Cber Led	Class I	21 CFR 874.4780	1	0
QJN	Laparoscopic Accessories, Esophageal Sizing	Class II	21 CFR 876.5360	2	0
QJP	Catheter, Percutaneous, Neurovasculature	Class II	21 CFR 870.1250	100	7
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Class II	21 CFR 882.5800	19	1
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Not classified		0	40
QJS	Interoperable Automated Glycemic Controller, Insulin Suspend	Class II	21 CFR 862.1356	1	0
QJT	Rigid Sterilization Container With Software	Class II	21 CFR 880.6855	1	0
QJU	Image Acquisition And/Or Optimization Guided By Artificial Intelligence	Class II	21 CFR 892.2100	9	0
QJX	Caries Detection Product With Drug Or Biologic	Class III		0	0
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	Class II	21 CFR 880.5725	4	0
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Class II	21 CFR 870.4100	4	2
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia	Class II	21 CFR 876.5510	4	0
QKB	Radiological Image Processing Software For Radiation Therapy	Class II	21 CFR 892.2050	49	0
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Class II	21 CFR 890.5360	0	0
QKD	Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use	Class II	21 CFR 890.5670	0	0
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Class I	21 CFR 862.1620	1	0
QKF	Immunocytochemistry Assay, P16/Ki-67	Class III	21 CFR 864.1860	0	0
QKH	Assisted Reproduction Laminar Flow Workstation	Class II	21 CFR 884.6120	0	0
QKI	Media, Reproductive, Exempt	Class II	21 CFR 884.6180	0	0
QKJ	Stent, Central Venous	Class III		0	0
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	Class II	21 CFR 878.5040	0	0
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	Class II	21 CFR 880.2800	5	0
QKO	Reagent, Coronavirus Serological	Not classified		0	31
QKP	Coronavirus Antigen Detection Test System.	Not classified		0	47
QKQ	Digital Pathology Image Viewing And Management Software	Class II	21 CFR 864.3700	15	0
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Not classified		0	1
QKS	Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led	Not classified		0	0
QKT	Clozapine Test System	Class II	21 CFR 862.3245	1	0
QKU	Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)	Not classified		0	0
QKV	Electromechanical Tear Stimulator	Class II	21 CFR 886.5305	2	0
QKW	Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis	Class II	21 CFR 888.3695	1	0
QKY	Decontamination Systems For N95 Respirators	Not classified		0	1
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Class II	21 CFR 876.1310	6	0
QLC	Interleukin 6	Not classified		0	0
QLD	Protective Barrier Enclosure	Not classified		0	0
QLE	Protective Barrier Enclosure With Negative Pressure	Not classified		0	0
QLF	On-Body Injector	Class II	21 CFR 880.5860	0	0
QLG	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems	Class II	21 CFR 862.1355	9	10
QLH	System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led	Not classified		0	0
QLI	Vaporizer, Cder Or Cber Led	Not classified		0	0
QLJ	Patient Monitor With Independent Remote Display And Operation	Not classified		0	0
QLK	Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief	Class III		0	0
QLL	Left Ventricular Ejection Fraction Screening Tool	Not classified		0	0
QLM	Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool	Not classified		0	0
QLN	Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19	Not classified		0	1
QLO	Immunoadsorption Column For Emergency Use	Not classified		0	0
QLQ	Manual Instruments Designed For Use With Total Disc Replacement Devices	Class II	21 CFR 888.4515	9	0
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices	Class II	21 CFR 888.4520	1	1
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Not classified		0	11