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 59 of 71

FDA product codes, page 59 of 71
Code	Device name	Class	Regulation	Clearances	Recalls
PKF	D And C Tray	Not classified		0	2
PKG	Bone Marrow Processing Device To Support Hematopoietic Reconstitution	Class II	21 CFR 864.9245	0	0
PKI	Fully Subcutaneous Implanted Hemodialysis Catheter	Class II	21 CFR 876.5540	0	0
PKJ	Crown And Bridge Material, Resin Based	Not classified		0	0
PKK	Stent Delivery System	Not classified		0	0
PKL	Hemostatic Metal Clip For The Gi Tract	Class II	21 CFR 876.4400	65	6
PKM	Chemiluminescent Immunoassay System	Not classified		0	0
PKN	Dilator, Cervical, Synthetic, Osmotic	Class II	21 CFR 884.4260	1	0
PKO	Transparent Patch For Use In Treatment Of Tattoos	Class II	21 CFR 878.4810	2	0
PKP	Immunoglobulin G (Igg) Infusion System	Class II	21 CFR 880.5725	7	0
PKQ	Computerized Cognitive Assessment Aid	Class II	21 CFR 882.1470	3	0
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Class II	21 CFR 882.5892	9	0
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Class I	21 CFR 890.5370	0	0
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	Class II	21 CFR 878.5400	19	0
PKU	Insulin Pump Secondary Display	Class II	21 CFR 862.1350	0	0
PKW	Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase	Class III		0	0
PKY	Implant, Dermal, For Aesthetic Use In The Hands	Class III		0	0
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Class II	21 CFR 870.5910	9	0
PLB	Multivariate Vital Signs Index	Class II	21 CFR 870.2300	8	0
PLC	Sleep Appliances With Patient Monitoring	Class II	21 CFR 872.5570	10	0
PLF	Bone Wedge	Class II	21 CFR 888.3030	18	9
PLH	Orthodontic Led Accessory	Class II	21 CFR 872.5470	2	0
PLI	Gastrointestional Tube Holder	Class II	21 CFR 876.5980	1	0
PLJ	Tissue Adhesive Internal Use	Class III	21 CFR 878.4010	0	0
PLK	Tympanic Membrane Direct Contact Hearing Aid	Class II	21 CFR 874.3315	3	0
PLL	Submucosal Injection Agent	Class II	21 CFR 876.1500	10	1
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	Class II	21 CFR 866.3970	4	2
PLP	High Intensity Ultrasound System For Prostate Tissue Ablation	Class II	21 CFR 876.4340	13	1
PLQ	Enzyme Packed Cartridge	Class II	21 CFR 876.5985	8	0
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	21 CFR 888.3060	19	0
PLS	Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1	Class III		0	2
PLU	Thermal System For Insomnia	Class II	21 CFR 882.5700	1	0
PLV	Dental Stereotaxic Instrument	Class II	21 CFR 872.4120	23	6
PLW	Acetabular Cup Orientation System	Class II	21 CFR 888.3350	1	0
PLX	Tear Duct Occluder	Class I	21 CFR 886.5838	1	0
PLY	Antimicrobial Drapes	Class II	21 CFR 878.4370	0	0
PLZ	Ocular Pattern Recorder	Class II	21 CFR 886.1925	1	0
PMB	External Airway	Class II	21 CFR 868.5105	1	0
PMC	Scalp Cooling System	Class II	21 CFR 878.4360	7	1
PME	External Cleaning Solution	Class II	21 CFR 872.3260	3	0
PMG	Automated Multicolor Fluorescent Imaging Cytometric Analysis System	Class II	21 CFR 864.5220	1	0
PMH	Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)	Humanitarian device exemption		0	0
PMI	Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement	Class III		0	0
PMJ	Cpr Aid Feedback Device (No Software)	Class II	21 CFR 870.5210	0	0
PMK	Cpr Aid Device Without Feedback	Class I	21 CFR 870.5210	2	0
PML	Bone Cement, Posterior Screw Augmentation	Class II	21 CFR 888.3027	19	2
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Class II	21 CFR 866.3920	32	4
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Class III		0	2
PMQ	Peripheral Blood Processing Device For Wound Management	Class II	21 CFR 864.9245	0	0
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	Class II	21 CFR 880.5725	5	0
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Class II	21 CFR 866.3215	5	1
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port	Class II	21 CFR 884.4050	4	1
PMV	Orthosis, Limb, For Back Pain	Class I	21 CFR 890.3475	1	0
PMW	Strabismus Detection Device	Class II	21 CFR 886.1342	1	1
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	Class III	21 CFR 878.4490	0	2
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	Class II	21 CFR 866.1640	3	0
PNA	Evoked Photon Image Capture Device	Class I	21 CFR 882.1561	1	0
PNB	Biliary Stent System For Benign Strictures	Class II	21 CFR 876.5011	1	0
PNC	Catheter Introducer	Not classified		0	0
PND	Midline Catheter	Class II	21 CFR 880.5200	13	10
PNE	Reprocessed Catheter Introducer	Class II	21 CFR 870.1340	7	0
PNF	Aortic Stent	Class III		0	0
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Class II	21 CFR 876.5630	15	13
PNI	Aquaporin-4 Autoantibody	Class II	21 CFR 866.5665	2	0
PNJ	Leadless Pacemaker	Class III	21 CFR 870.3610	0	6
PNK	Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)	Class II	21 CFR 864.1890	0	0
PNL	Magnetic Surgical System	Class II	21 CFR 878.4815	8	0
PNN	Orthodontic Software	Class II	21 CFR 872.5470	35	2
PNO	Catheter, Percutaneous, Cutting/Scoring	Class II	21 CFR 870.1250	46	3
PNP	Dental Abutment Design Software For Dental Laboratory	Class II	21 CFR 872.3630	8	0
PNQ	Apical Closure Device	Class II	21 CFR 870.4510	1	0
PNR	Enteral Syringes With Enteral Specific Connectors	Class II	21 CFR 876.5980	34	4
PNS	Short-Term Intravascular Filter Catheter	Class II	21 CFR 870.3375	1	0
PNU	Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery	Class II	21 CFR 884.5210	1	0
PNV	Impedance Measuring Device Utilizing Oscillation Techniques	Class II	21 CFR 868.1840	4	0
PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant	Class III		0	1
PNY	Absorbable Coronary Drug-Eluting Stent	Class III		0	1
PNZ	Eustachian Tube Balloon Dilation Device	Class II	21 CFR 874.4180	9	0
POA	Reagents, Zika Virus Nucleic Acid	Not classified		0	1
POC	System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen	Class II	21 CFR 866.1640	4	0
POD	Temporary, Internal Use Hemostatic	Class II	21 CFR 878.4454	6	1
POE	Extended Depth Of Focus Intraocular Lens	Class III	21 CFR 886.3600	0	1
POG	Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid	Not classified		0	0
POH	Mr-Guided Focused Ultrasound System	Class III		0	0
POI	Lung Tissue Sealant For Lung Volume Reduction	Not classified		0	0
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Class II	21 CFR 892.2060	23	0
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Class II	21 CFR 882.5600	18	3
POM	Computerized Cognitive Assessment Aid For Concussion	Class II	21 CFR 882.1471	8	0
PON	Catheter, Balloon, Dilation Of Cervical Canal	Class II	21 CFR 884.4260	4	0
POP	Cranial Motion Measurement Device	Class II	21 CFR 882.1630	2	0
POQ	Blood Transfusion Kit	Class II	21 CFR 880.5440	0	5
POR	Parenteral Administration Kit	Class II	21 CFR 880.5440	0	0
POS	Physiological Signal Based Seizure Monitoring System	Class II	21 CFR 882.1580	10	1
POT	Lockbox (Export Only)	Not classified		0	0
POV	Semen Analysis Device	Class II	21 CFR 864.5220	28	2
POW	Crown And Bridge, Long-Term Temporary, Resin	Class II	21 CFR 872.3770	2	0
POX	Enzyme Immunoassay, Oxcarbazepine Metabolite	Class II	21 CFR 862.3645	1	0
POY	Post Breast Biopsy Hemostatic Breast Compression Device	Class II	21 CFR 892.1710	1	0
POZ	Biopsy Needle Kit	Class II	21 CFR 876.1075	0	1
PPA	Bladder Irrigation Kit	Class II	21 CFR 876.5130	0	0