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 66 of 71

FDA product codes, page 66 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
QQT	Immunohistochemistry Assay, Antibody, Ki-67	Class III		0	0
QQU	Digital Therapy Device For Amblyopia	Class II	21 CFR 886.5500	5	0
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Class II	21 CFR 866.3378	4	0
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Class II	21 CFR 866.3981	11	0
QQY	Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms	Class II	21 CFR 866.2190	2	0
QRA	Virtual Reality Behavioral Therapy Device For Pain Relief	Class II	21 CFR 890.5800	6	1
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Class III		0	0
QRC	Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation	Class II	21 CFR 876.5026	4	0
QRF	Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer	Class III		0	2
QRG	Ultrasound Guided Nerve Block Assist	Class II	21 CFR 868.1980	3	0
QRH	Catheter, Balloon, Urethral, Drug-Coated	Class III		0	0
QRI	Surgical Planning Software For Neurological Stereotaxic Instruments	Class II	21 CFR 882.4560	1	0
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Class II	21 CFR 870.5125	1	0
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	Class II	21 CFR 878.4850	17	0
QRL	Multiple Use Blood Lancet For Single Patient Use Only	Class II	21 CFR 878.4850	27	1
QRM	Multiple Use Blood Lancet For Multiple Patient Use	Class III	21 CFR 878.4850	0	0
QRN	Radiation Therapy Marking Device	Class II	21 CFR 892.5785	2	0
QRQ	Non-Irrigation Endosseous Dental Implant Drill Bits	Class I	21 CFR 872.3980	0	0
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside	Class II	21 CFR 888.3046	2	0
QRS	Device For Sleep Apnea Testing Based On Mandibular Movement	Class II	21 CFR 868.2376	3	0
QRU	Implant, Resorbable, For Articular Osteochondral Repair	Class III		0	0
QRV	Setmelanotide Eligibility Gene Variant Detection System	Class II	21 CFR 862.1164	1	0
QRX	Continuous Glucose Monitor Informed Insulin Dose Calculator	Class II	21 CFR 862.1358	6	2
QRY	Dental Navigation System	Class II	21 CFR 872.4120	5	3
QRZ	External Condom For Anal Intercourse Or Vaginal Intercourse	Class II	21 CFR 884.5305	1	0
QSA	Circulating Tumor Cell (Ctc) Enrichment Device	Class II	21 CFR 866.6110	1	0
QSB	Orthosis, Truncal, Pregnancy	Class I	21 CFR 890.3490	1	0
QSD	Posterior Cervical Screw Placement Guide	Class II	21 CFR 888.3075	2	0
QSE	Alzheimer’S Disease Pathology Assessment Test	Class II	21 CFR 866.5840	3	0
QSF	Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents	Class III		0	1
QSH	Coronavirus Marker Detection	Not classified		0	0
QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	Class III		0	0
QSL	Brain Temperature Measurement System	Class II	21 CFR 882.1565	1	0
QSM	System, Surgical, Computer Controlled Instrument, Remanufactured	Class II	21 CFR 876.1500	8	0
QSN	Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System	Class II	21 CFR 866.3988	1	1
QSO	Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs	Class II	21 CFR 878.4040	1	0
QSQ	Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms	Class II	21 CFR 882.5888	1	0
QSR	Sacroiliac Screw Placement Guide	Class II	21 CFR 888.3040	1	0
QSS	Hiv Self-Tests	Class III		0	0
QST	Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test	Class II	21 CFR 866.3957	0	0
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Class II	21 CFR 866.3956	0	0
QSV	Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test	Class II	21 CFR 866.3957	0	0
QSW	Endoscopic Traction Device	Class II	21 CFR 876.4410	2	0
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unclassified		18	0
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unclassified		127	0
QSZ	Absorbable Synthetic Wound Dressing	Unclassified		21	0
QTA	Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis	Not classified		0	0
QTB	Nitric Oxide Generator And Delivery System	Class III		0	0
QTC	Adult Portable Bed Rails For Medical Purposes	Class I	21 CFR 890.5050	0	2
QTD	Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	Class II	21 CFR 876.5983	2	0
QTE	Thymidine Kinase Activity	Class II	21 CFR 866.6010	1	0
QTF	Reprocessed Atherectomy Catheter	Class II	21 CFR 870.4875	1	8
QTG	Infant Supine Sleep System	Class II	21 CFR 880.5690	1	3
QTH	Endoscopic Light-Projecting Measuring Device	Class II	21 CFR 876.1530	1	0
QTI	Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device	Class II	21 CFR 880.5200	1	0
QTK	Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device	Humanitarian device exemption		0	0
QTM	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.	Class II	21 CFR 866.3920	0	0
QTN	Orally Ingested Transient Device For Constipation	Class II	21 CFR 876.5940	3	0
QTO	Digital Visual Acuity Test	Class I	21 CFR 886.1150	1	0
QTP	Reagents, Monkeypox Virus Nucleic Acid.	Not classified		0	0
QTQ	Reagents, Non-Variola Orthopoxvirus Nucleic Acid.	Not classified		0	0
QTT	Over The Counter Electrical Salivary Stimulatory System	Class II	21 CFR 872.5560	2	0
QTU	Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests	Not classified		0	0
QTV	Mattress And Bed Deck Cover (Medical Purposes)	Class I	21 CFR 880.6190	1	0
QTW	Digital Amsler Grid	Class I	21 CFR 886.1330	1	0
QTY	Von Willebrand Factor Assay	Class II	21 CFR 864.7293	1	0
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation	Class II	21 CFR 892.2050	9	0
QUA	Intraoral Cooling Device	Class II	21 CFR 872.5590	2	0
QUB	Suction Lipoplasty System For Removal And Transfer	Class II	21 CFR 878.5040	0	0
QUD	Blood Detection Capsule	Class II	21 CFR 876.1390	1	0
QUE	Spinal Muscular Atrophy Newborn Screening Test System	Class II	21 CFR 866.5980	1	0
QUF	Hearing Aid, Air-Conduction, Over The Counter	Class I	21 CFR 874.3300	0	0
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Class II	21 CFR 874.3305	0	1
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Class II	21 CFR 874.3325	10	0
QUJ	Automated Cryopreservation Storage System	Class II	21 CFR 884.6120	1	0
QUK	Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test	Class II	21 CFR 866.5960	0	0
QUL	Immunohistochemistry Assay, Antibody, Folr1	Class III	21 CFR 864.1860	0	0
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Class II	21 CFR 866.3958	0	0
QUN	Tether Accessory For Use In The Gastrointestinal Tract	Class II	21 CFR 876.1305	0	0
QUO	Adjunctive Heart Failure Status Indicator	Class II	21 CFR 870.2200	4	0
QUQ	Knife, Intraocular Pressure Lowering	Class II	21 CFR 878.4400	1	0
QUR	Prescription Spectacle Lenses To Reduce The Progression Of Myopia	Class II	21 CFR 886.5845	1	0
QUT	Deformability Cytometry For Sepsis Risk Assessment	Class II	21 CFR 866.3215	3	0
QUU	Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples	Class II	21 CFR 866.3046	2	0
QUV	Phase-Changing Fiducial Marker For Radiation Therapy	Class II	21 CFR 892.5727	1	0
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	Class II	21 CFR 878.3300	5	0
QVA	Fludeoxyglucose F18-Guided Radiation Therapy System	Class II	21 CFR 892.5060	2	3
QVB	Biological Sterilization Indicator With Indirect Growth Detection	Class II	21 CFR 880.2806	3	0
QVC	Ventilator Waveform Analysis Software	Class II	21 CFR 868.5896	1	0
QVD	Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan	Class II	21 CFR 892.2055	1	0
QVE	Adjunctive Pain Measurement Device For Anesthesiology	Class II	21 CFR 868.2200	1	0
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Class II	21 CFR 866.3982	10	0
QVG	Embolization Agent, Vascular	Class III		0	0
QVI	Screw Sleeve Bone Fixation Device, Spine	Class II	21 CFR 888.3043	2	0
QVJ	Low Power Electrosurgical Devices For Skin Lesion Destruction	Class II	21 CFR 878.4400	4	0
QVL	Absorbable Gel For Intraoperative Use In Spine Surgery	Class II	21 CFR 888.3047	2	0
QVN	Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus	Class II	21 CFR 874.3410	1	0
QVO	Computerized Behavioral Therapy Device For Insomnia	Class II	21 CFR 882.5801	2	0
QVP	Sars-Cov-2 Serology Test	Class II	21 CFR 866.3983	5	0
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Class II	21 CFR 870.4600	2	0