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 |
|---|---|---|---|---|---|
| K023665 | Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery | Bioplate Inc | JEY | Class II | |
| K023636 | Blocking Tray | Southeastern Radiation Products, Inc. | IYE | Class II | |
| K023555 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K023352 | Validate Chem 9 Calibration Verification Test Set, Model 109 | Maine Standards Co. | JJY | Class I | |
| K023252 | Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020 | Icn Biomedicals, Inc. | DJR | Class II | |
| K023110 | Cedars-Sinai Motion Correction (Moco) Software, Model 111005 | Digirad Corp. | KPS | Class II | |
| K022975 | Etching 15 | Ab Ardent | EBF | Class II | |
| K022974 | Microhybrid 12 | Ab Ardent | EBF | Class II | |
| K022973 | Adhesive 14 | Ab Ardent | KLE | Class II | |
| K022972 | Microfill 13 | Ab Ardent | EBF | Class II | |
| K022970 | Amicas Light Beam Workstation, Model 1.0 | Amicas, Inc. | LLZ | Class II | |
| K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips North America LLC | JAA | Class II | |
| K022827 | Ultrafix Knotless Minimite Suture Anchor | Linvatec Corporation | MBI | Class II | |
| K022817 | Cooltouch Nd:yag Laser System, Model Cooltouch, Cooltouch-II Nd:yag Laser System, Model Cooltouch-II | Icn Pharmaceuticals, Inc. | GEX | Class II | |
| K022746 | Stat Profile Critical Care Xpress Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K022057 | Kg Medix Disposable Syring, 1,3,5,10, 20, 30, 50 Ml's,kg Medix | Kyung GI Medical Ind. Co., Ltd. | FMI | Class II | |
| K021846 | 804Siii; 804W; Libra TENS; 410; S-TENS II | Body Clock Health Care Ltd | GZJ | Class II | |
| K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization | Biosphere Medical, S.A. | NAJ | Class II | |
| K021112 | Inspiration Ventilator System | Event Medical Ltd | CBK | Class II | |
| K023711 | Digital Thermometer Classic Type and Flexible Type | Acute Ideas Co., Ltd. | FLL | Class II | |
| K023622 | Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35 | Stockert Instrumente GmbH | DWF | Class II | |
| K023585 | Flostar Needleless Connector, Model Fs3000 | Intravascular Incorporated | FPA | Class II | |
| K023573 | Wizair Compression System | Medical Compression Systems (Dbn), Ltd. | JOW | Class II | |
| K023426 | Trx Vertical Positioner | Motion Concepts LP | ITI | Class II | |
| K022916 | Blood Pressure Monitor Smartlogic, Models Kp-6210 and Kp-6211 | K-Jump Health Co., Ltd. | DXN | Class II | |
| K022860 | Atlantis Pv Imaging Catheter, Model 36456 | Boston Scientific Corporation | ITX | Class II | |
| K022799 | Trident Screw Hole Plug and Trident Bone Spike | Howmedica Osteonics Corp | JDI | Class II | |
| K022652 | Alphatrac, Model a 205 | Teftec Corp. | ITI | Class II | |
| K022464 | Equilase System | Equilasers, Inc. | GEX | Class II | |
| K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id, Model 9043G0102 | Medtronic Functional Diagnostics A/S | MYE | Class II | |
| K023720 | Sonoline Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K023584 | Ascensia Dex 2 Diabetes Care System | Bayer Corp. | NBW | Class II | |
| K023571 | 6 Channel Body Coil | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K023473 | Sonoreal 3D | Bio Medi Com | IYO | Class II | |
| K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | LLZ | Class II | |
| K022779 | Oti Unicondular Interpositional Spacer | Osteoimplant Technology, Inc. | HSH | Class II | |
| K021789 | Quicklab Rsv | Integrated Biotechnology Corp. | GQG | Class I | |
| K021444 | Cynosure Photogenica Sv | Cynosure, LLC | GEX | Class II | |
| K023749 | The M3810a Philips Telemonitoring System with M3812b Telestation (M310a/12b) | Philips North America LLC | DRG | Class II | |
| K023698 | M3290a Intellivue Information Center Software Release E.o | Philips North America LLC | MHX | Class II | |
| K023680 | Biobuck Cement Restrictor | Smith & Nephew, Inc. | LZN | Class II | |
| K023606 | Tilite Yg and Tilite Ygs | TiSport, LLC | IOR | Class I | |
| K023601 | Rubicor Encapsule Breast Biopsy Device, Model 30086 | Rubicor Medical, Inc. | GEI | Class II | |
| K023589 | Storm Tdx Power Wheelchair | Invacare GmbH | ITI | Class II | |
| K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K023521 | Easy Life | Berkline Corp. | INO | Class II | |
| K023516 | Monarc Sling System | American Medical Systems, Inc. | OTN | Class II | |
| K022986 | The Bioplate Battery Powered Drill | Bioplate Inc | HBC | Class II | |
| K022925 | Electro-Nerve Stimulator TENS Model Bmls02-10 | BioMedical Life Systems Inc. | GZJ | Class II | |
| K022841 | Electro-Nerve Stimulator TENS, Model Bmls02-9 | BioMedical Life Systems Inc. | GZJ | Class II |