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 |
|---|---|---|---|---|---|
| K022798 | Cervive Anterior Cervical Plating System, Model Number 157.Xxx Series Catalogue Numbers | Corin USA | KWQ | Class II | |
| K022783 | Tl100 Tensmeter Blood Pressure Monitoring System | Tensys Medical, Inc. | DXN | Class II | |
| K022777 | Manual Touche System | Onux Medical, Inc. | GAQ | Class II | |
| K022687 | Aosept Clear Care Cleaning and Disinfecting Solution | Alcon Laboratories | LYL | Class II | |
| K022539 | Phfw-10 | Pihsiang Machinery Mfg. Co., Ltd. | ITI | Class II | |
| K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics GmbH | NBC | Class II | |
| K021980 | Hip Module for the Stealthstation System | Medtronic Navigation, Inc | HAW | Class II | |
| K021867 | Insound Xt Series Hearing Aid | Insound Medical, Inc. | ESD | Class I | |
| K021767 | Assufil | Assut Europe S.p.A. | GAM | Class II | |
| K021679 | Oria Spinal Clip System | Ortho Tec, LLC | KWP | Class II | |
| K020804 | Auto Suture Premium Plus Ceea Disposable Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | NFJ | Class II | |
| K023679 | Gore 3.0T Torso Array | W. L. Gore & Associates, Inc. | MOS | Class II | |
| K023635 | Sri/surgical Express Sp Reusable Surgical Gown | Sri/Surgical Express | FYA | Class II | |
| K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 | Boston Scientific Corporation | KTI | Class II | |
| K023184 | Ethanol Assay for the Bayer Advia Integrated Module System | Bayer Diagnostics Corp. | DIC | Class II | |
| K023126 | Ameditech Immutest Hcg Pregancy Test | Ameditech, Inc. | LCX | Class II | |
| K022760 | Millennium Microsurgical System | Bausch & Lomb Incorporated | GEX | Class II | |
| K022671 | Freeform Blue Powderfree Nitrile Examination Gloves | Hartalega Sdn Bhd | LZA | Class I | |
| K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | NJR | Class I | |
| K021615 | Baxter Accura System, Model 5M5660 | Baxter Healthcare Corporation | KDI | Class II | |
| K014140 | Renax Hemodialysis Blood Tubing Set; Sunder Hemodialysis Blood Tubing Set | Sunder Biomedical Tech. Co., Ltd. | FJK | Class II | |
| K023747 | Phaseal | Carmel Pharma AB. | LHI | Class II | |
| K023558 | Pts Panels Lipid Panel Test Strips | Polymer Technology Systems | CHH | Class I | |
| K023268 | Phoenix Ise Standard A,b and C for Roche/avl Systems | Phoenix Diagnostics, Inc. | JIX | Class II | |
| K023095 | Hermes Operating Room Control Center | Computer Motion, Inc. | GCJ | Class II | |
| K022982 | Med-Logics Microkeratome Blade, Model 7050Clb | Med-logics Inc | HNO | Class I | |
| K022821 | Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E | Ideatrics, Inc. | DZK | Class II | |
| K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration System | Medtronic Percusurge, Inc. | NFA | Class II | |
| K011618 | Calgitrol Ag Silver Alginate Wound Dressing | Adri | FRO | Unclassified | |
| K011518 | Vitalsat Series | Beta Biomed Services, Inc. | DQA | Class II | |
| K023503 | Skintact ECG Electrode | Leonhard Lang GmbH | DRX | Class II | |
| K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion Pf Nailing System), Fixion Intramedullary Nail | Disco-O-Tech Medical Technologies, Ltd. | HSB | Class II | |
| K023434 | Dorex Spectrum 9000Mb Thermography System | Dorex, Inc. | LHQ | Class I | |
| K023034 | Cardiotouch-3000 | Bionet Co., Ltd. | LOS | ||
| K022934 | Silentflow 2 Exhalation System, Model Wm 23650 | Gottlieb Weinmann Geraete Fuer Medizin und Arbeits | BZD | Class II | |
| K022900 | Butler Gum Vari-Clean Power Toothbrushes | John O. Butler Co. | JEQ | Class I | |
| K022753 | Reprocesses Used Disposable Sequential Compression Sleeves/wraps | Medical Device Services | JOW | Class II | |
| K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-Cicu02 & L-Cicu02a Software | GE Healthcare | MLD | Class II | |
| K022731 | V TENS Plus | Body Clock Health Care Ltd | GZJ | Class II | |
| K022729 | Vented Cement Restrictor | Amedica Corp. | JDX | Class II | |
| K021565 | Luther Safety Huber Needle Set | Luther Research Partners | FPA | Class II | |
| K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | MWJ | Class II | |
| K023646 | Exatech Acumatch Integrated Hip System C-Series Cemented Femoral Stem | Exactech, Inc. | JDI | Class II | |
| K023645 | Spi Easy Dental Implant Abutment | Thommen Medical AG | NHA | Class II | |
| K023562 | Modification to Classic Great Toe Implant | Nexa Orthopedics, Inc. | KWH | Class II | |
| K023504 | Modification to Atb All-Terrain Balloon Pta Dilatation Catheter | Cook Inc. | LIT | Class II | |
| K023498 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | KWP | Class II | |
| K023493 | Pk Zip Wing Cutting Dissector | Gyrus ACMI, Inc. | GEI | Class II | |
| K023492 | Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps | Gyrus ACMI, Inc. | GEI | Class II |