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 63 of 71

FDA product codes, page 63 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
QBX	Direct Blood Bacterial Nucleic Acid Detection System	Class II	21 CFR 866.3960	2	0
QBY	Positive Airway Pressure System	Class II	21 CFR 868.5273	2	0
QBZ	Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma	Class I	21 CFR 862.2750	0	0
QCA	Intracranial Coil-Assist Stent	Class III		0	2
QCB	Phakic Toric Intraocular Lens	Class III	21 CFR 886.3600	0	5
QCC	Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals	Class II	21 CFR 862.1358	5	0
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use	Class III		0	0
QCF	Electrical Tongue Stimulator To Treat Motor Deficits	Class II	21 CFR 882.5889	2	0
QCG	Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions	Not classified		0	0
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Class II	21 CFR 866.3920	1	0
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Class II	21 CFR 882.5802	9	0
QCJ	Closed Loop Auto Titration Device For Oral Appliances	Class II	21 CFR 872.5571	1	0
QCL	Acid-Sphingomyelinase (Asm) Newborn Screening Test System	Class II	21 CFR 862.1488	0	0
QCM	ß-Galactocerebrosidase (Galc) Newborn Screening Test System	Class II	21 CFR 862.1488	0	0
QCR	Wound Autofluorescence Imaging Device	Class I	21 CFR 878.4165	1	0
QCT	Scaffold, Dissection Repair	Class III		0	1
QCU	Dengue Virus Antigen Assay	Class II	21 CFR 866.3945	1	0
QCW	Corneal Storage Media With Preservatives Including Anti-Fungal	Class II	21 CFR 886.4320	1	0
QCX	Retrograde Intubation Set	Class II	21 CFR 868.5095	1	0
QCY	Laser Absorbing Particles	Class II	21 CFR 878.4810	2	0
QCZ	Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator	Class III		0	0
QDA	Electrocardiograph Software For Over-The-Counter Use	Class II	21 CFR 870.2345	9	0
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	Class II	21 CFR 870.2790	5	0
QDC	Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies	Class II	21 CFR 866.6100	2	0
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Class II	21 CFR 874.3325	7	0
QDF	Parathyroid Autofluorescence Detection Device	Class II	21 CFR 878.4550	1	0
QDG	Parathyroid Autofluorescence Imaging Device	Class II	21 CFR 878.4550	6	0
QDH	Menopause Test System	Class II	21 CFR 862.1093	1	0
QDI	Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies	Class II	21 CFR 864.1880	1	1
QDJ	Direct-To-Consumer Access Pharmacogenetic Assessment System	Class II	21 CFR 862.3364	3	0
QDK	Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management	Class II	21 CFR 862.1355	4	0
QDL	Integrated Continuous Glucose Monitoring System For Professional Retrospective Use	Class II	21 CFR 862.1355	1	0
QDM	Midazolam Syringe	Class II	21 CFR 880.5860	0	0
QDO	Fentanyl And Other Opioid Protection Glove	Class I	21 CFR 880.6250	0	0
QDP	Respiratory Panel	Class II	21 CFR 866.3985	2	0
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Class II	21 CFR 892.2090	40	0
QDR	Plazomicin Test System, Immunoassay	Class II	21 CFR 862.3460	1	1
QDS	Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System	Class II	21 CFR 866.4001	3	5
QDT	Shoe With Adjustable Sole Units	Class I	21 CFR 890.3475	1	0
QDV	Iol Tray	Class I	21 CFR 886.4350	0	0
QDW	Phaco Kit	Class II	21 CFR 886.4670	0	0
QDY	Vitrectomy Kit	Class II	21 CFR 886.4150	0	0
QDZ	Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection	Class II	21 CFR 866.3181	2	0
QEA	Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid	Class II	21 CFR 882.1455	7	2
QEB	Ventilatory Electrical Impedance Tomograph	Class II	21 CFR 868.1505	6	0
QEC	Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree	Class II	21 CFR 876.4300	1	0
QEF	Pressure Ulcer Management Tool	Class I	21 CFR 876.2100	1	0
QEH	Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	Class II	21 CFR 880.5860	5	0
QEI	Breast Milk Macronutrients Test System	Class II	21 CFR 862.1493	3	1
QEJ	Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries	Class II	21 CFR 876.4100	2	0
QEK	Angiographic Coronary Vascular Physiologic Simulation Software	Class II	21 CFR 870.1415	2	0
QEM	Cerebral Oximeter	Class II	21 CFR 870.2700	1	0
QEO	Light Attenuation Lenses For Migraine-Associated Light Sensitivity	Class I	21 CFR 882.5811	1	0
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Class II	21 CFR 866.3393	24	4
QER	Camera, Ophthalmic, Slit-Scanning	Class II	21 CFR 886.1120	3	0
QES	Reherniation Reduction Device	Class III		0	1
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class II	21 CFR 870.5150	145	10
QEX	Coronary Mechanical Thrombectomy With Aspiration	Class II	21 CFR 870.5150	3	0
QEY	Mechanical Thrombolysis Catheter	Class II	21 CFR 870.5150	71	4
QEZ	Aspiration Thrombectomy Catheter	Class II	21 CFR 870.5150	95	0
QFA	Assay For Detection Of Proteases In Chronic Wounds	Class II	21 CFR 866.3231	1	0
QFB	Isocapnic Ventilation Device	Class II	21 CFR 868.5480	1	0
QFC	Negative Pressure Wound Therapy Device For Reduction Of Wound Complications	Class II	21 CFR 878.4783	3	1
QFD	Tens For Sinus Pain	Class II	21 CFR 882.5890	0	0
QFF	Electromechanical Arm For A Transcranial Magnetic Stimulation System	Class II	21 CFR 882.5805	2	0
QFG	Alternate Controller Enabled Insulin Infusion Pump	Class II	21 CFR 880.5730	29	22
QFI	Synthetic Next-Generation Sequencing Quality Control And Filler Material	Not classified		0	0
QFJ	Intravascular Bleed Monitor	Class II	21 CFR 870.1345	2	1
QFK	Tumor Gene Profiling Test	Not classified		0	0
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Class II	21 CFR 892.2080	41	0
QFO	Zika Virus Serological Reagents	Class II	21 CFR 866.3935	4	0
QFP	Intraoperative Orthopedic Strain Sensor	Class II	21 CFR 888.3090	1	0
QFQ	Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss	Class II	21 CFR 876.5982	3	0
QFR	Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties	Class II	21 CFR 864.5430	8	0
QFS	Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment	Class II	21 CFR 866.3215	1	0
QFT	Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder	Class II	21 CFR 882.5803	4	0
QFV	Implantable Pulse Generator	Class III		0	1
QFX	Diagnostic Neurosurgical Microscope Filter	Class II	21 CFR 882.4950	5	0
QFZ	Gastroenterology-Urology Accessories To A Biopsy Instrument	Class I	21 CFR 876.1080	0	0
QGA	Penile Implant Surgical Accessories	Class I	21 CFR 876.3500	0	0
QGB	Ureteral Stent Accessories	Class I	21 CFR 876.4630	0	0
QGC	Suprapubic Catheter Accessories	Class I	21 CFR 876.5100	0	0
QGD	Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories	Class I	21 CFR 876.5290	0	0
QGE	Biliary Stent, Drain, And Dilator Accessories	Class I	21 CFR 876.5012	0	0
QGG	Esophageal Sheath With Distal Balloon Anchor	Class II	21 CFR 876.1510	1	0
QGH	Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder	Class II	21 CFR 882.5940	9	0
QGI	Air-Handling Apparatus Accessory	Class I	21 CFR 878.5080	0	0
QGJ	Corneal Inlay Inserter Handle	Class I	21 CFR 886.4355	0	0
QGK	Balloon, Nasal Airway	Class I	21 CFR 874.4420	1	0
QGL	Transcutaneous Nerve Stimulator For Adhd	Class II	21 CFR 882.5898	5	0
QGM	Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation	Class II	21 CFR 878.4405	3	0
QGN	Lateral Flow Immunochromatography Assay For Host Infection Biomarkers	Class II	21 CFR 866.3230	2	0
QGO	Composite Resin Warmer	Class I	21 CFR 872.6100	1	0
QGP	Posterior Ratcheting Rod System	Not classified		0	0
QGQ	Bone Indentation Device	Class II	21 CFR 888.1600	3	0
QGT	Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine	Class II	21 CFR 882.5899	7	1
QGU	Hemoglobin For Donor Testing	Class II	21 CFR 864.7500	0	0
QGX	General Use Pneumatic Tourniquet	Class I	21 CFR 878.5910	0	0
QGY	Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera	Class II	21 CFR 876.1500	1	0
QGZ	Electrical Tumor Treatment Fields	Class III		0	0