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 |
|---|---|---|---|---|---|
| K021347 | Modification to M2376a Devicelink System | Philips North America LLC | MWI | Class II | |
| K021325 | Modification of Apexpro Telemetry System | General Electric Medical Systems Information Techn | MHX | Class II | |
| K021287 | Trillium Affinity Nt Cardiotomy Venous Reservoir, Models 540T, 541Tt | Medtronic Perfusion Systems | DTN | Class II | |
| K021251 | St/ar St and Arrhythmia Software, Release E.i. | Philips North America LLC | DSI | Class II | |
| K020720 | Ossiform | Unicare Biomedical, Inc. | LYC | Class II | |
| K020612 | Sultan Sporox Test Vial, Model 75195 | Sultan Chemists, Inc. | JOJ | Class II | |
| K020452 | High Silver Conventional | Ab Ardent | EJJ | Class II | |
| K012716 | Mainstream Water Purification Device | Prismedical Corp. | NHV | Class II | |
| K012195 | Steam Sterilization Intergrator | Dana Products, Inc. | JOJ | Class II | |
| K021037 | Microstrep Plus Panel with Ampicillin | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K020937 | Microscan Microstrep Plus Panel-Amoxicillin/clavulanic Acid | Dade Microscan, Inc. | JWY | Class II | |
| K020917 | Saview 55F (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear | St. Shine Optical Co., Ltd. | LPL | Class II | |
| K020781 | Wet Chamber | KCI USA, Inc. | NAD | Class I | |
| K020716 | Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards (Up to Six Tests) | Rapid Diagnostics, Inc. | DJG | Class II | |
| K020679 | Inratio | Hemosense, Inc. | GJS | Class II | |
| K020627 | Microscan Microstrep Plus Panel New Antimicrobial-Gatifloxacin | Dade Microscan, Inc. | LTT | Class II | |
| K020625 | Spife 2000/3000 Alp 40, 20; Models 3345 and 3346 | Helena Laboratories, Corp. | CIN | Class II | |
| K020384 | T2 Arthrodesis Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K020383 | Ortho Development Balanced Knee Tibial Tray Pegged | Ortho Development Corp. | JWH | Class II | |
| K020381 | Expandable Knee | Biomet Orthopedics, Inc. | KRO | Class II | |
| K020379 | Ppd Balloon Dilatation Catheter | TeleMed Systems | KNT | Class II | |
| K020377 | Pre-Loaded Biostinger Hornet | Linvatec Corporation | HWC | Class II | |
| K011690 | Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray | Proxima Therapeutics, Inc. | JAQ | Class II | |
| K021245 | Degotzen Synchro | The Gotzen Group, Inc. | EHD | Class II | |
| K021244 | Ace Ha Screw Dental Implant System | Ace Surgical Supply Co., Inc. | DZE | Class II | |
| K021216 | Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps | Sterling Medivations, Inc. | FPA | Class II | |
| K021108 | Esop Ha Femoral Stem | Fournitures Hospitalieres | MEH | Class II | |
| K021106 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K021091 | Ebi Xfix Dfs System | Ebi, LLC | KTT | Class II | |
| K021038 | Gc Elite Cement 100 | GC America Inc. | EMA | Class II | |
| K020876 | Echoscan, Model US-1800 | Nidek, Inc. | IYO | Class II | |
| K020797 | Pulmo-Mist Compressor Model # 4323 | Nidek Medical Products Inc | BTI | Class II | |
| K020760 | Starflow Hv | Danville Materials, Inc. | EBF | Class II | |
| K020554 | Modification to Universal Total Wrist System | Kinetikos Medical, Inc. | JWJ | Class II | |
| K020510 | Smoke Evacuation Hoses/tubing | Dm Medical, Inc. | FYD | Class II | |
| K020476 | Medion 6000 | Spectramed, LLC | EGJ | Class II | |
| K020393 | Master & Frank Surgical Drapes (Sterile) | Master & Frank Enterprses Co., Ltd. | KKX | Class II | |
| K020375 | The Nurture III Breast Pump | Bailey Medical Engineering | HGX | Class II | |
| K020374 | Oculight Sl/slx | Iridex Corporation | HQF | Class II | |
| K020365 | 3Tm Myocardial Needle-Temperature Probe | 3T Medical Systems Inc. | KRI | Class I | |
| K020354 | Baylis Pain Management Generator (Pmg), Models Pmg-115 (Domestic), Pmg-230 (International) | Baylis Medical Co., Inc. | GXD | Class II | |
| K014126 | Sanidad Health-Up TENS Mp-73725 | Roc Chinese-European Industrial Research Society | GZJ | Class II | |
| K014068 | Elcomed, Models Sa-200 C 230, Sa-200 230, Sa-200 C 115, Sa-200 115 | W & H DentalWerk Buermoos GmbH | EBW | Class I | |
| K012800 | Symmetric Unicompartmental Knee System | Whiteside Biomechanics, Inc. | HRY | Class II | |
| K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | KNT | Class II | |
| K011426 | Psychemedics Ria Cannabinoid Assay | Psychemedics Corp. | LAT | Class II | |
| K021285 | Hi-Torque Extra S'port Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K021284 | Easytrak Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K021283 | Guidant Balloon Catheter, Several Models | Boston Scientific Corporation | DQO | Class II | |
| K021282 | Lv-1 Hemostasis Valve, Model #6789 | Boston Scientific Corporation | DTL | Class II |