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 |
|---|---|---|---|---|---|
| K081980 | Kymco Foru, Model Eq35 | Besteam Technology, Inc. | INI | Class II | |
| K081859 | Modification to Onedose Patient Dosimetry System | Sicel Technologies, Inc. | IYE | Class II | |
| K081510 | Tiger Cannulated Screw System | Trilliant Surgical LLC | HWC | Class II | |
| K081319 | Dimension Clinical Chemistry System Lipase Calibrator, Model Dc56 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K081289 | V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device | Baxter Healthcare Corporation | FPA | Class II | |
| K081017 | Template and Counter-Fit | Den-Mat Holdings, LLC | ELW | Class II | |
| K080749 | Radiance | American Orthodontics | NJM | Class II | |
| K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | GXY | Class II | |
| K073381 | Plexus Ebv Igm Multi-Analyte Diagnostics, Model: Mp0600m | DiaSorin Molecular LLC | LJN | Class I | |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220 | GE Healthcare | MHX | Class II | |
| K082043 | Carriazo-Pendular Microkeratome | Schwind Eye-Tech-Solutions GmbH & Co. KG | HNO | Class I | |
| K082041 | Fiatlux Visualize | Fiatlux Imaging, Inc. | LLZ | Class II | |
| K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating | Osteomed | KWD | Class II | |
| K081085 | Starchmark Biopsy Site Marker, Model Stmkec-10Gss, Stmkec-10Gtr, Stmkmt-11Gs | Senorx, Inc. | NEU | Class II | |
| K080037 | Modification to Zilver 635 Biliary Stent | Cook Inc. | FGE | Class II | |
| K073677 | Scanscope Xt System | Leica Biosystems Imaging, Inc. | NQN | Class II | |
| K073523 | Interceptor Plus Coronary Filter Systems | Medtronic, Inc. | NFA | Class II | |
| K073112 | Da Vinci Sonicpro Cleaning System, Model 400253 | Intuitive Surgical, Inc. | NVE | Class II | |
| K082033 | Nannolight Intense Pulsed Light System | Global USA Distribution, LLC | GEX | Class II | |
| K082031 | Appasamy Slit Lamp, A1a-11 and A1a-12 Series | Appasamy Associates | HJO | Class II | |
| K081954 | Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable | Gyrus ACMI, Inc. | GEI | Class II | |
| K081870 | Masimo Compatible Saturation Module, E-Masimo | GE Healthcare Finland Oy | DQA | Class II | |
| K081552 | Skyline 55 | Larsen & Toubro Limited | MWI | Class II | |
| K081444 | Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring System | Braemar Manufacturing, LLC | DSI | Class II | |
| K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, Inc. | FTM | Class II | |
| K081124 | Mdf Revision Hip System | Smith & Nephew, Inc. | MEH | Class II | |
| K080552 | Cyto-Chex Bct | Streck LLC | GIM | Class II | |
| K080370 | Abl 80 Co-Ox System | Sendx Medical, Inc. | CHL | Class II | |
| K080326 | Kd-391 Semi Automatic Electronic Blood Pressure Monitor | Andon Health Co., Ltd | DXN | Class II | |
| K073042 | Hemosil D-Dimer | Instrumentation Laboratory Co. | DAP | Class II | |
| K072109 | Statmap, Model 7200 | Ramsey Medical, Inc. | DXN | Class II | |
| K081879 | Spsmedical Sporview Pa Culture Set | Spsmedical Supply Corp. | MRB | Class II | |
| K081836 | Carestream Dr Long Length Imaging System for Dr 7500 System | Eastman Kodak Company | KPR | Class II | |
| K081698 | Mainstream or Surgical Light Control (Mslc) | Image Stream Medical, Inc. | FTA | Class II | |
| K081466 | Sterile, Powder Free Nitrile Examination Gloves, Blue | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K081429 | Thd Slide | Thd SpA | JAF | Class II | |
| K081244 | Lower Extremity External Fixation - Expanded Indications | Biomet Trauma | KTT | Class II | |
| K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook Inc. | FOZ | Class II | |
| K080995 | Modification to Affymetrix Genechip Microarray Instrumentation System | Affymetrix Inc | NSU | Class II | |
| K080896 | Pathwork Diagnostics Tissue of Origin Test | Pathwork Diagnostics, Inc. | OIW | Class II | |
| K080832 | Stockert S5 System, Stockert Gas Blender | LivaNova Deutschland GmbH | DTQ | Class II | |
| K080780 | Anchorage Scope, Model 000003 | Epitek, Inc. | FBO | Class II | |
| K080745 | Genadyne A4 Powered Suction Pump | Genadyne Biotechnologies, Inc. | BTA | Class II | |
| K080668 | G2 Express Filter System-Femoral (Rf400f) and Jugular/subclavian (Rf400j) Delivery Kits | C.R. Bard Inc | DTK | Class II | |
| K073386 | Joint Stim, Model 1000 | Pain Management Technologies | NYN | Class II | |
| K072884 | Fabius MRI | Draeger Medical AG & Co. KG | BSZ | Class II | |
| K071759 | Ltc Vad System, Models #Vad.400 (Electrosurgical Generator); Pcs-900 and Pcc-900 (Hand Piece Instruments) | Live Tissue Connect, Inc. | GEI | Class II | |
| K081964 | K450 Powered Wheelchair | Permobil, AB | ITI | Class II | |
| K081760 | Rsvp Phantom Pelvis, Model Tlp260 | Phantom Laboratory | IYE | Class II | |
| K081678 | Conmed Beamer System C600 | Kls Martin GmbH + Co. KG | GEI | Class II |