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 , the FDA export date. FDA product classification database
Review panels
6,880 codes| 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 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| LOQ | Device, General Purpose, Hematology | Class II | 21 CFR 866.6010 | 1 | 1 |
| LOT | Pulse-Generator, Program Module | Class III | 0 | 0 | |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class II | 21 CFR 870.5100 | 88 | 121 |
| LOZ | Artificial Heart | Class III | 0 | 5 | |
| LPA | System, Esophageal Pacing | Class III | 0 | 5 | |
| LPB | Cardiac Ablation Percutaneous Catheter | Class III | 0 | 21 | |
| LPC | Device, Angioplasty, Laser, Coronary | Class III | 0 | 4 | |
| LPF | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | Class III | 0 | 0 | |
| LPG | Material, Dressing, Surgical, Polylactic Acid | Class III | 0 | 7 | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | 21 CFR 888.3358 | 565 | 297 |
| LPI | Kit, Assay, Progesterone Receptor | Class III | 21 CFR 864.1860 | 0 | 0 |
| LPJ | Kit, Assay, Estrogen Receptor | Class III | 21 CFR 864.1860 | 0 | 1 |
| LPL | Lenses, Soft Contact, Daily Wear | Class II | 21 CFR 886.5925 | 487 | 70 |
| LPM | Lenses, Soft Contact, Extended Wear | Class III | 21 CFR 886.5925 | 0 | 26 |
| LPN | Accessories, Soft Lens Products | Class II | 21 CFR 886.5928 | 121 | 23 |
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | Class III | 21 CFR 886.4270 | 0 | 1 |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | Class II | 21 CFR 868.2500 | 2 | 1 |
| LPQ | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep | Class II | 21 CFR 890.5870 | 0 | 2 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | Class II | 21 CFR 862.1377 | 29 | 18 |
| LPT | System, Test, Urinary Methylmalonic Acid | Class II | 21 CFR 862.1509 | 0 | 1 |
| LPW | System, Test, Oxalate | Class I | 21 CFR 862.1542 | 1 | 0 |
| LPX | Radioceptor Assay, Neuroleptic Drugs | Class II | 21 CFR 862.3645 | 0 | 0 |
| LPZ | Container, Frozen Donor Tissue Storage | Unclassified | 6 | 0 | |
| LQA | Media, Reusable Image | Class I | 21 CFR 892.1840 | 1 | 0 |
| LQB | Medical Computers And Software For Ophthalmic Use | Class III | 2 | 0 | |
| LQC | Lithotriptor, Biliary Mechanical | Class II | 21 CFR 876.4500 | 11 | 7 |
| LQD | Recorder, Attention Task Performance | Unclassified | 11 | 0 | |
| LQE | Implant, Corneal, Refractive | Class III | 0 | 3 | |
| LQF | Dna-Reagents, Mycobacterium Spp. | Class I | 21 CFR 866.3370 | 15 | 2 |
| LQG | Dna-Reagents, Mycoplasma Spp. | Class I | 21 CFR 866.3375 | 1 | 1 |
| LQH | Dna-Reagents, Legionella | Class II | 21 CFR 866.3300 | 2 | 0 |
| LQI | Hepatitis Delta Serological Reagents | Class III | 0 | 0 | |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | Class II | 21 CFR 886.4390 | 13 | 1 |
| LQK | Home Uterine Activity Monitor | Class II | 21 CFR 884.2730 | 6 | 1 |
| LQL | Gram Positive Identification Panel | Class I | 21 CFR 866.2660 | 11 | 7 |
| LQM | Gram Negative Identification Panel | Class I | 21 CFR 866.2660 | 7 | 2 |
| LQN | Latex Agglutination Assay, Rubella | Class II | 21 CFR 866.3510 | 13 | 0 |
| LQO | Dna-Reagents, Campylobacter Spp. | Class I | 21 CFR 866.3110 | 4 | 0 |
| LQP | Campylobacter Spp. | Class I | 21 CFR 866.3110 | 12 | 1 |
| LQQ | Columns, Immunoadsorption In Extracorporeal Systems | Class III | 1 | 1 | |
| LQR | Dislodger, Stone, Biliary | Class II | 21 CFR 876.5010 | 38 | 11 |
| LQS | Spermatocele, Alloplastic | Unclassified | 1 | 0 | |
| LQW | Test, Temperature Discrimination | Class I | 21 CFR 882.1200 | 3 | 0 |
| LQX | Device, Finger-Sucking | Class I | 21 CFR 890.3475 | 2 | 0 |
| LQY | Locator, Root Apex | Unclassified | 46 | 0 | |
| LQZ | Device, Jaw Repositioning | Class II | 21 CFR 872.5570 | 27 | 0 |
| LRA | Hearing Aid, Tactile | Unclassified | 8 | 0 | |
| LRB | Face Plate Hearing Aid | Class I | 21 CFR 874.3300 | 24 | 0 |
| LRC | Instrument, Ent Manual Surgical | Class I | 21 CFR 874.4420 | 65 | 5 |
| LRD | Applicator, Ent Drug | Class I | 21 CFR 874.5220 | 6 | 1 |
| LRE | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile | Class I | 21 CFR 874.3540 | 0 | 0 |
| LRF | Candida Spp., Direct Antigen, Id | Class II | 21 CFR 866.3165 | 3 | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Class II | 21 CFR 866.1640 | 45 | 13 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | Class I | 21 CFR 866.2660 | 4 | 0 |
| LRI | Ph Meter For Dialysis Hydrogen Ion Concentration | Class II | 21 CFR 876.5820 | 1 | 0 |
| LRJ | Disinfectant, Medical Devices | Class I | 21 CFR 880.6890 | 73 | 17 |
| LRK | Device, Anti-Snoring | Class II | 21 CFR 872.5570 | 215 | 10 |
| LRL | Cushion, Hemorrhoid | Unclassified | 3 | 0 | |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | Class II | 21 CFR 866.5100 | 29 | 3 |
| LRN | Wire, Surgical | Class II | 21 CFR 888.3030 | 8 | 1 |
| LRO | General Surgery Tray | Class II | 21 CFR 878.4370 | 110 | 1,070 |
| LRP | Tray, Surgical | Class I | 21 CFR 878.4800 | 22 | 109 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | Class I | 6 | 4 | |
| LRR | First Aid Kit With Drug | Not classified | 15 | 30 | |
| LRS | I.V. Start Kit | Class II | 21 CFR 880.5200 | 30 | 165 |
| LRT | Indicator, Sterilization | Class II | 21 CFR 880.2800 | 5 | 1 |
| LRW | Scissors, General, Surgical | Class I | 21 CFR 878.4800 | 18 | 20 |
| LRX | Case, Contact Lens | Class II | 21 CFR 886.5928 | 82 | 0 |
| LRY | Punch, Surgical | Class I | 21 CFR 878.4800 | 7 | 6 |
| LRZ | Screwdriver, Surgical | Class I | 21 CFR 878.4800 | 3 | 6 |
| LSA | Vise, Bench, Surgical | Class I | 21 CFR 878.4800 | 1 | 0 |
| LSB | Unit, Fluidotherapy | Class II | 21 CFR 890.5100 | 4 | 0 |
| LSC | Neisseria Controls | Class I | 21 CFR 866.2660 | 7 | 0 |
| LSD | Rubella, Other Assays | Class II | 21 CFR 866.3510 | 0 | 0 |
| LSE | Epstein-Barr Virus, Other | Class I | 21 CFR 866.3235 | 56 | 7 |
| LSF | Dna-Reagents, Epstein-Barr Virus | Class I | 21 CFR 866.3235 | 0 | 0 |
| LSG | Candida Species, Antibody Detection | Class II | 21 CFR 866.3165 | 0 | 0 |
| LSH | Antigen, Blastomyces Dermatitidis, Other | Class II | 21 CFR 866.3060 | 0 | 0 |
| LSI | Antiserum, Blastomyces Dermatitidis, Other | Class II | 21 CFR 866.3060 | 0 | 1 |
| LSJ | Antigen, Rubella, Other | Class II | 21 CFR 866.3510 | 0 | 0 |
| LSK | Dna-Reagents, Chlamydia | Class I | 21 CFR 866.3120 | 8 | 1 |
| LSL | Dna-Reagents, Neisseria | Class II | 21 CFR 866.3390 | 45 | 7 |
| LSM | Dna-Reagents, Salmonella Spp. | Class II | 21 CFR 866.3550 | 0 | 1 |
| LSN | Dna-Reagents, Shigella Spp. | Class II | 21 CFR 866.3660 | 0 | 0 |
| LSO | Dna-Reagents, Cytomegalovirus | Class II | 21 CFR 866.3175 | 0 | 1 |
| LSQ | Reagent, Rickettsia Serological | Class I | 21 CFR 866.3500 | 4 | 0 |
| LSR | Reagent, Borrelia Serological Reagent | Class II | 21 CFR 866.3830 | 112 | 5 |
| LSW | Anti-Dna Antibody, Antigen And Control | Class II | 21 CFR 866.5100 | 8 | 1 |
| LSX | Controller, Closed-Loop, Blood-Pressure | Class III | 0 | 0 | |
| LSY | Ultrasound, Hyperthermia, Cancer Treatment | Class III | 0 | 0 | |
| LSZ | Ventilator, High Frequency | Class III | 0 | 7 | |
| LTA | Fluid, Hysteroscopy | Class III | 0 | 0 | |
| LTB | Cyclosporine Radioimmunoassay | Class II | 21 CFR 862.1235 | 1 | 0 |
| LTC | Hyaline Membrane Disease Assay | Class III | 1 | 0 | |
| LTD | Paraquat Assay | Class III | 2 | 1 | |
| LTF | Stimulator, Salivary System | Class II | 21 CFR 872.5560 | 2 | 35 |
| LTG | Paste, Injectable For Vocal Cord Augmentation | Class III | 0 | 0 | |
| LTI | Implant, Intragastric For Morbid Obesity | Class III | 0 | 26 | |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | Class II | 21 CFR 866.6010 | 34 | 12 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | Class II | 21 CFR 866.6010 | 26 | 8 |
