510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K972058 | Loripro, Loripro II | Lori Medical Laboratories, Inc. | ESD | Class I | |
| K972046 | Full Body Restraint System | Gillen Industries | FMQ | Class I | |
| K971964 | Oxlife Excell Oxygen Concentrators | Oxlife, Inc. | CAW | Class II | |
| K971951 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K971937 | Climber - Partially Coated Guide Wire for Endoscopic Use | Terumo Medical Corp. | OCY | Class II | |
| K971852 | Air Conduction Haearing Aids | Beltone Electronics Corp. | ESD | Class I | |
| K971848 | Tdk Medical Grade Cd-R | Tdk Electronics Corporation of America | LMB | Class I | |
| K971845 | Heartland Technologies, Ite, Itc, Cic | Sound Hearing Instruments, Inc. | ESD | Class I | |
| K971839 | Varian Radiation Therapy Imaging System | Varian Medical Systems, Inc. | KPQ | Class II | |
| K970849 | Enteral Nutrition 1000 Ml/500ml | Medical Infusion Technologies, Inc. | KNT | Class II | |
| K970436 | E-Reader | Natural Herbal Products, Inc. | GZO | Class II | |
| K970348 | Siemens Sc/9000/sc9015 Series Surgical Display Controller | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K970305 | Printer Interface | Micromedical, Inc. | DXH | Class II | |
| K970115 | Powder Free Latex Examination Gloves | Pt Mbf Buana Multicorpora | LYY | Class I | |
| K964594 | Vaportrode Vaporization Electrode -Grooved/fluted/spiked(gve-B,gve-F,gve-S) & Vaportomme Vaporization Loop (Gve-Lg) | Circon Corp. | KNF | Class II | |
| K963668 | Medisystems Peritoneal Dialysis Sets | Medisystems Corp. | KDJ | Class II | |
| K972766 | Pivoting Compensating Filters for the Head | Octostop, Inc. | KPR | Class II | |
| K972566 | Dexon Violet | Davis & Geck, Inc. | GAM | Class II | |
| K972110 | Cordis Endeavor Infusion Catheter | Cordis US Corp. | QEY | Class II | |
| K972062 | Convatec Non-Adhesive Dressing | Convatec, A Division of E.R. Squibb & Sons | KMF | Class I | |
| K972054 | Innova Rectal Reusable Electrode/comfortpulse Regular or Small Reusable Electrode | Empi | KPI | Class II | |
| K971953 | Confoscan | Tomey Corporation USA | HJO | Class II | |
| K971941 | Aqua Spray | Boyd Industries, Inc. | GEY | Class I | |
| K971930 | Bk-N Sealing Cap | BIOTRONIK AG | DTD | Class II | |
| K971879 | Scanning Device Accessory for Use with the Cb Erbium/2.94 Er:yag Laser | Continuum Biomedical, Inc. | GEX | Class II | |
| K971830 | Accu-Pulse Carbon Dioxide Laser System | Argus Photonics Group | GEX | Class II | |
| K971609 | Sculpture | Servizi Medico Estetici Italinai SRL. | LFL | Unclassified | |
| K971542 | Ortho Dx Neuromuscular Stimulator | Rehabilicare, Inc. | IPF | Class II | |
| K971540 | American Biosurgical Electrosurgical Monopolar Cable/cord | American Biosurgical, Inc. | GEI | Class II | |
| K971026 | The Circulator Boot | Circulator Boot Corp. | DRN | Class II | |
| K970635 | Titanium Spinal Rod System | Smith & Nephew, Inc., Orthopaedic Div. | KWQ | Class II | |
| K970388 | A1-A,abp,b,mbp, Lead Connectors; Peh Adapter Sleeve | BIOTRONIK AG | DTD | Class II | |
| K970241 | Depuy Proximal Femoral Replacement Prosthesis | Depuy, Inc. | LPH | Class II | |
| K965124 | Lasette | Cell Robotics, Inc. | GEX | Class II | |
| K964738 | Elpha 2000 Conti | Dan Med, Inc. | KPI | Class II | |
| K964176 | Tecno Reusable, Electrosurgical, Bipolar Forceps | Tecno Instruments (USA), Inc. | GEI | Class II | |
| K963336 | Harmac Thermodilution Catheter | Harmac Medical Products | DYG | Class II | |
| K963073 | Harmac Bipolar Temporary Pacing Catheter with Stylet | Harmac Medical Products | LDF | Class II | |
| K972819 | Vigil Tdm Controls | Beckman Instruments, Inc. | DIF | Class I | |
| K972627 | Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056) | Pacific Hemostasis | GJT | Class II | |
| K972482 | Reaads Protein S Antigen Test Kit | Reaads Medical Products, Inc. | GGP | Class II | |
| K972182 | Abbott Strep a Controls | Abbott Diagnostics | MJZ | Class I | |
| K972005 | Reaads Von Willebrand Factor Antigen Test Kit | Reaads Medical Products, Inc. | GGP | Class II | |
| K971867 | Alice 4R System | Healthdyne Technologies, Inc. | OLV | Class II | |
| K971632 | Ticarcillin/clavulanic Acid Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K964784 | Synergy Cardiology Information System (00431) | Quinton, Inc. | DPS | Class II | |
| K972797 | Tool-Less Wheel Chair | Sunrise Medical, Inc. | IOR | Class I | |
| K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary Reagents | Roche Diagnostic Systems, Inc. | JFJ | Class II | |
| K972235 | Precicontrol Tumor Marker 1 and 2 | Boehringer Mannheim Corp. | JJY | Class I | |
| K972209 | Spectrolyse Heparin (Anti-Iia) | Medical Diagnostic Technologies, Inc. | KFF | Class II |