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 |
|---|---|---|---|---|---|
| PPB | Foley Catheter Kit (Excludes Hiv Testing) | Class II | 21 CFR 876.5130 | 0 | 14 |
| PPC | Male External Catheterization Kit (Excludes Hiv Testing) | Class II | 21 CFR 876.5130 | 0 | 0 |
| PPD | Universal Drainage Tray | Class II | 21 CFR 876.5130 | 0 | 4 |
| PPE | Nephroscope Set | Class II | 21 CFR 876.1500 | 0 | 0 |
| PPF | Urinary Irrigation Kit | Class II | 21 CFR 876.5130 | 0 | 0 |
| PPG | Urinary Drainage Collection Kit | Class II | 21 CFR 876.5130 | 0 | 1 |
| PPH | Single Needle With Uni-Directional Pump Kit | Class II | 21 CFR 876.5820 | 0 | 0 |
| PPI | Hemodialysis Tray (Not A Start/Stop Kit) | Class II | 21 CFR 876.5820 | 0 | 0 |
| PPJ | Peritoneal Dialysis Administration Kit | Class II | 21 CFR 876.5630 | 0 | 0 |
| PPK | Peritoneal Dialysis Tubing Kit | Class II | 21 CFR 876.5630 | 0 | 0 |
| PPL | Single Needle (Co-Axial Flow) Dialysis Kit | Class II | 21 CFR 876.5820 | 0 | 0 |
| PPM | General Purpose Reagent | Class I | 21 CFR 864.4010 | 16 | 30 |
| PPN | Percutaneous Catheter, Ultrasound | Class II | 21 CFR 870.1250 | 14 | 1 |
| PPO | Multi-Lumen Hemodialysis Catheterization Kit | Class II | 21 CFR 876.5540 | 0 | 2 |
| PPP | Disposable Joint Aspiration/Injection Kit | Class I | 21 CFR 878.4800 | 0 | 0 |
| PPQ | Transtibial Anterior Cruciate Ligament Kit | Class II | 21 CFR 888.3040 | 0 | 0 |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | Class II | 21 CFR 888.1100 | 0 | 1 |
| PPS | Sleeve, Head And Neck, Compressible | Class II | 21 CFR 870.5800 | 1 | 0 |
| PPT | Cranial Surgical Planning And Instrument Guides | Class II | 21 CFR 882.4310 | 4 | 0 |
| PPU | Microbial Colony Image Assessment System | Class II | 21 CFR 866.2190 | 3 | 0 |
| PPW | Adjunctive Cardiovascular Status Indicator | Class II | 21 CFR 870.2200 | 8 | 0 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | Class II | 21 CFR 866.3975 | 12 | 3 |
| PQC | Pedicle Screw Placement Guide | Class II | 21 CFR 888.3070 | 8 | 0 |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Class II | 21 CFR 862.1675 | 0 | 1 |
| PQE | Ostomy Care Kit | Class I | 21 CFR 876.5900 | 0 | 1 |
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | Class III | 0 | 4 | |
| PQH | Iodinated Contrast Media Transfer Tubing Set | Class II | 21 CFR 880.5440 | 6 | 0 |
| PQI | Wound Retraction And Protection System | Class II | 21 CFR 878.4371 | 2 | 0 |
| PQJ | Intranasal Electrostimulation Device | Class II | 21 CFR 886.5300 | 1 | 0 |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | Class II | 21 CFR 870.1252 | 7 | 1 |
| PQM | Surgical Smoke Precipitator | Class II | 21 CFR 878.5050 | 7 | 0 |
| PQN | Carbon Dioxide Gas Controlled Tissue Expander | Class II | 21 CFR 878.3510 | 3 | 0 |
| PQO | Anti-Müllerian Hormone Test System | Class II | 21 CFR 862.1092 | 5 | 1 |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | Class III | 0 | 18 | |
| PQQ | Data Acquisition Software | Class II | 21 CFR 862.2570 | 0 | 1 |
| PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | Class II | 21 CFR 862.1488 | 0 | 0 |
| PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | Class II | 21 CFR 862.1488 | 0 | 0 |
| PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | Class II | 21 CFR 862.1488 | 0 | 0 |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | Class II | 21 CFR 862.1488 | 3 | 0 |
| PQX | Epinephrine Syringe | Class II | 21 CFR 880.5860 | 2 | 0 |
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | Class II | 21 CFR 890.5290 | 2 | 0 |
| PQZ | Gbs Culture Media, Selective And Differential | Class I | 21 CFR 866.2360 | 4 | 3 |
| PRA | Variola Virus Nucleic Acid-Based Detection Assay | Class II | 21 CFR 866.3316 | 1 | 0 |
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | Class II | 21 CFR 864.1865 | 2 | 3 |
| PRC | Drug-Coated Peripheral Transluminal Angioplasty Catheter | Class III | 0 | 1 | |
| PRE | Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers | Class II | 21 CFR 866.3215 | 4 | 0 |
| PRF | Docetaxel / Paclitaxel Assay | Not classified | 0 | 0 | |
| PRH | Positive Blood Culture Identification And Ast Kit | Class II | 21 CFR 866.1650 | 2 | 4 |
| PRI | Procalcitonin Assay | Class II | 21 CFR 866.3215 | 8 | 1 |
| PRJ | Capillary Blood Collection Device For Alternative Site Collection | Class II | 21 CFR 862.1675 | 2 | 0 |
| PRK | Device Indicating An Exhalation Event | Class II | 21 CFR 868.2375 | 1 | 0 |
| PRL | Iliac Covered Stent, Arterial | Class III | 0 | 6 | |
| PRM | Enteral Administration Kit (Adult & Pediatric) | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRN | Pediatric Position Holder | Class I | 21 CFR 880.5680 | 0 | 0 |
| PRO | Anti-Regurgitation Blood Tubing Kit | Class II | 21 CFR 876.5820 | 0 | 0 |
| PRP | Balloon Gastrostomy Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRQ | Esophageal Dilator Kit | Class II | 21 CFR 876.5365 | 0 | 0 |
| PRR | Feeding Tube Kit | Class II | 21 CFR 876.5980 | 0 | 1 |
| PRS | Gastric Colonic Catheter Irrigation Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRT | Gastric Irrigation And Aspiration Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRU | Gastric Lavage Kit (Adult Or Pediatric Use) | Class II | 21 CFR 876.4370 | 0 | 0 |
| PRV | Gastro-Urology Biopsy Kit | Class II | 21 CFR 876.1075 | 0 | 1 |
| PRW | Gastrointestinal Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRX | Gastrostomy Guide Wire Placement Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRY | Gastrostomy Jejunostomy Feeding Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PRZ | Gastrostomy Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSA | Laparoscopic Jejunostomy Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSB | Nasogastric Feed Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSC | Nasogastric-Gastrojejunal Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSD | Laparoscopic Gastrostomy Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSE | Needle Catheter Jejunostomy Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSF | Non-Balloon Replacement Gastrostomy System | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSG | Percutaneous Endoscopic Gastrostomy Kit | Class II | 21 CFR 876.5980 | 0 | 1 |
| PSH | Percutaneous Replacement Gastrostomy Tube Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSI | Perineal Irrigation Kit | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSJ | Rectal Dilator Kit | Class I | 21 CFR 876.5450 | 0 | 0 |
| PSK | Replacement Gastrostomy Feeding Catheter Tray | Class II | 21 CFR 876.5980 | 0 | 0 |
| PSL | 25-Oh-Vitamin D Mass Spectrometry Test System | Class II | 21 CFR 862.1840 | 1 | 0 |
| PSM | Refractometer For Donor Testing | Class I | 21 CFR 862.2800 | 0 | 0 |
| PSN | Light Based Imaging | Class II | 21 CFR 878.4580 | 10 | 0 |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | Class II | 21 CFR 882.1620 | 0 | 1 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | Class II | 21 CFR 870.3470 | 11 | 2 |
| PSR | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | Class III | 0 | 0 | |
| PSS | Minoxidil Sulfotransferase Or Isoenzymes Test System | Not classified | 0 | 0 | |
| PST | Aortic Annuloplasty Ring | Class II | 21 CFR 870.3800 | 2 | 0 |
| PSU | Jak2 Gene Mutation Detection Test | Class II | 21 CFR 866.6070 | 2 | 0 |
| PSV | Ultrasound Bronchoscope | Class II | 21 CFR 892.1550 | 4 | 2 |
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class II | 21 CFR 892.1570 | 7 | 0 |
| PSX | Chlorine Meter | Class II | 21 CFR 876.5665 | 1 | 0 |
| PSY | Whole Slide Imaging System | Class II | 21 CFR 864.3700 | 23 | 2 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Class II | 21 CFR 866.3328 | 73 | 5 |
| PTA | Genetic Variant Detection And Health Risk Assessment System | Class II | 21 CFR 866.5950 | 5 | 0 |
| PTB | Ataxiagraph With Interpretive Software | Class I | 21 CFR 882.1030 | 0 | 0 |
| PTC | Uric Acid Test System For At Home Prescription Use | Class I | 21 CFR 862.1775 | 3 | 2 |
| PTD | Subcutaneous Implanted Apheresis Port | Class II | 21 CFR 880.5965 | 3 | 0 |
| PTE | Endoscopic Morcellator Gastroenterology | Class II | 21 CFR 884.1690 | 2 | 0 |
| PTF | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | Class II | 21 CFR 866.3215 | 4 | 1 |
| PTG | Test, Methadone, Over The Counter | Class II | 21 CFR 862.3620 | 0 | 0 |
| PTH | Test, Barbiturate, Over The Counter | Class II | 21 CFR 862.3150 | 1 | 0 |
| PTI | Non-Coring (Huber) Needle | Class II | 21 CFR 880.5570 | 14 | 12 |
