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 |
|---|---|---|---|---|---|
| K082252 | Independence Spacer | Globus Medical, Inc. | OVD | Class II | |
| K082101 | Ls Family of CO2 Lasers with Scanning Handpiece | Sandstone Medical Technologies, LLC | GEX | Class II | |
| K081858 | Retcam 3 Ophthalmic Imaging System | Clarity Medical Systems | HKI | Class II | |
| K081145 | Modification to 4Cis Vane Spine System | Solco Biomedical Corp. | MNI | Class II | |
| K081026 | Body Control System Family, Body Control Duo and Ct5 | Sport-Elec | NGX | Class II | |
| K080217 | Component Neuromonitoring System | Moberg Research, Inc. | OMA | Class II | |
| K083147 | Discovery Mr450 | GE Healthcare | LNH | Class II | |
| K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent Kit | Astoria-Pacific, Inc. | NAK | Class II | |
| K082933 | Passeo-35 Pta Catheter | BIOTRONIK AG | DQY | Class II | |
| K082646 | Optimus 0.035 Pta Balloon Dilatation Catheter | Usci Ireland | DQY | Class II | |
| K082215 | Osteoraptor Suture Anchor | Smith & Nephew, Inc. | JDR | Class II | |
| K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates | Zimmer GmbH | HRS | Class II | |
| K082050 | Liaison Hav Igm Assay, Liaison Control Hav Igm | Diasorin Inc. | LOL | Class II | |
| K083135 | Modification to Chillbuster Portable Electric Blanket , Model 8002 | Thermogear, Inc. | DWJ | Class II | |
| K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | IYN | Class II | |
| K082981 | Diamondback 360 Degree Orbital Atherectomy System with Viperslide Lubricant | Cardiovascular Systems Incorporated | MCW | Class II | |
| K082966 | Pb 540 Ventilator | Covidien, Formerly Nellcor Puritan Bennett, Inc. | CBK | Class II | |
| K082945 | Starlight | Orthomerica Products, Inc. | OAN | Class II | |
| K082942 | Modfication to: Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K082821 | Spinesmith Partners, Lp Cequence Anterior Cervical Plate System | Spine Smith Partners L.P. | KWQ | Class II | |
| K082410 | Master3ds | E-Woo Technology | OAS | Class II | |
| K082305 | G2 Express Filter System - Femoral and Jugular/subclavian Delivery Kits | C.R. Bard Inc | DTK | Class II | |
| K082290 | Neuron Delivery Catheter 070 | Penumbra Inc. | DQY | Class II | |
| K081741 | Neurolink Ip, Model Pk1113 | Excel-Tech Ltd. (Xltek) | GWQ | Class II | |
| K081312 | Aragon Oneshot System | Aragon Surgical, Inc. | GEI | Class II | |
| K080979 | Stageone Select Cement Spacer Molds for Temporary Hip Replacement | Biomet Manufacturing Corp | KWY | Class II | |
| K080527 | Twinguard with Capnograph Accessory | Trawax Pty Limited | CCK | Class II | |
| K080254 | Scanscope Xt System | Leica Biosystems Imaging, Inc. | OEO | Class II | |
| K080057 | Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control | Novx Systems, Inc. | DKZ | Class II | |
| K072752 | Bp Limbo Xl, Bptango Xl, Bp Salsa Xl | Datadancer Medical Systems | DQK | Class II | |
| K083066 | Chromophare E 778 and E 558 | Berchtold Holding GmbH | FSY | Class II | |
| K082906 | Unity Beta Anchor System | Bonutti Research, Inc. | HWC | Class II | |
| K082717 | Audit Microcv Tumor Markers Linearity Set, Model K719m-5 | Aalto Scientific Ltd. | JJY | Class I | |
| K082667 | Visionsense Stereoscopic Vision System (Vs System) | Visionsense, Ltd. | EOB | Class II | |
| K082530 | Applicators for Afterloading Brachytherapy | Isodose Control B.V. | JAQ | Class II | |
| K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751 | Dale Medical Products, Inc. | KNT | Class II | |
| K082178 | Tephaflex Absorbable Suture | Tepha, Inc. | NWJ | Class II | |
| K082171 | Gradia Core | GC America Inc. | EBF | Class II | |
| K081857 | Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models Dr 306, Dc 306 | Siemens Healthcare Diagnostics Inc. | NRP | Class II | |
| K081724 | Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan) Wound Gel | Applied Nutritionals | KGN | Unclassified | |
| K083021 | Apex Hp M Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator | Corcym Inc. | DTZ | Class II | |
| K082847 | Pinnacle Roii Introducer Sheath | Terumo Medical Corp. | DYB | Class II | |
| K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (Twin200). | Microlife Intellectual Property GmbH | DXN | Class II | |
| K082267 | Pigalileo Cas, Version 4.0 and Tkr Base, Version 2.1 | Smith & Nephew, Inc. | HAW | Class II | |
| K082198 | Durashield Plus | Dentsply Intl. | LBH | Class II | |
| K082163 | Flowmedica Benephit Infusion Systems | Flowmedica, Inc. | KRA | Class II | |
| K073307 | Max-Face Maxillofacial Osteosynthesis System | Bio-Technology USA, Inc. | JEY | Class II | |
| K082901 | Kymco Foru, Model Eq20 | Kwang Yang Motor Co., Ltd. | INI | Class II | |
| K082900 | Kymco Foru, Model Eq10 | Kwang Yang Motor Co., Ltd. | INI | Class II | |
| K082870 | Vti Intraoperative Doppler Systems | Vascular Technology Incorporated | DPW | Class II |