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 |
|---|---|---|---|---|---|
| K070273 | Modification to Nuvasive Lateral Plate System | NuVasive Inc | KWQ | Class II | |
| K063791 | Corin Unipolar Modular Head | Corin USA | KWL | Class II | |
| K062963 | Pharos Excimer Laser System, Model Ex-308 | Ra Medical Systems,Inc | GEX | Class II | |
| K062083 | Synfix -Lr | Synthes Spine Co.Lp | MQP | Class II | |
| K070673 | Force Fiber Black Co-Braid Polyethylene Non-Absorbable Surgical Suture | Teleflexmedical, Inc. | GAT | Class II | |
| K070655 | Wu's Powered Wheelchair, Mambo 36 | Wu's Tech Co., Ltd. | ITI | Class II | |
| K070644 | Gore Seamguard Staple Line Reinforcement Material for Circular Staplers | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K070602 | C.t.m. Mobility Scooter# Hs-265 | C.T.M. Homecare Product, Inc. | INI | Class II | |
| K070546 | Lyphochek Diabetes Control | Bio-Rad Laboratories Inc. | GGM | Class II | |
| K070233 | Conmed Linvatec Smart Guard Irrigator | Conmed Linvatec | HRX | Class II | |
| K070016 | Blue Shark | Meridan Medical | KTT | Class II | |
| K063216 | Rescue Internal Implant System | Megagen Co., Ltd. | DZE | Class II | |
| K063159 | Sterilox Liquid Chemical Sterilant System | Puricore, Inc. | MED | Class II | |
| K063061 | Cortrak Enteral Access Device, Model 20-0900 | Viasys Medsystems | KNT | Class II | |
| K062957 | Fastpack Total Psa Method Verification Kit | Qualigen Inc | JJX | Class I | |
| K070729 | Balanceback Mobile Intuitive Vng System | Fall Prevention Technologies, LLC | GWN | Class II | |
| K070215 | Tokuyama Bond Force | Tokuyama Dental Corporation | KLE | Class II | |
| K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec | DZL | Class II | |
| K063674 | Ezmanager Max Diabetes Management Software | Animas Corp. | LZG | Class II | |
| K063321 | D-Carie/detectar, Models N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | NBL | Class II | |
| K062120 | Cisbio Renin Ria Test | Cis Bio International | CIB | Class II | |
| K050415 | Impedimed-Extracellular Fluid Analysis | Impedimed, Inc. | OBH | Class II | |
| K070698 | Coe Comfort | GC America Inc. | EBI | Class II | |
| K070697 | Coe Soft | GC America Inc. | EBI | Class II | |
| K070635 | Hemosil Proclot | Instrumentation Laboratory Co. | GGP | Class II | |
| K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K070548 | C-Port Flexa Distal Anastomosis System | Cardica, Inc. | FZP | Class II | |
| K070525 | Charlotte 7.0 Multi-Use Compression Screw and Washer | Wrightmedicaltechnologyinc | HWC | Class II | |
| K070507 | Modification to: Ligafix Interference Screw | Science for Biomaterials | HWC | Class II | |
| K070447 | Newdeal Compression Plate | Newdeal SAS | HRS | Class II | |
| K070402 | Modification to Polar Care 500 | Breg, Inc. | ILO | Class II | |
| K070384 | Argon Continuous Flush Device | Argon Medical Devices, Inc | KRA | Class II | |
| K070334 | R&d Sickle Qc Control | R & D Systems, Inc. | GGM | Class II | |
| K070177 | Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K070127 | Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02 | Kevin Vu, Dds | EMN | Class I | |
| K063874 | Drill for Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | DZE | Class II | |
| K063452 | Ma 55 Maestro | Maico Diagnostics (Diagnostic Group, LLC) | EWO | Class II | |
| K063076 | Reprocessed Diagnostic Ultrasound Catheter | Stryker Sustainability Solutions | OWQ | Class II | |
| K070712 | Modification to: Yelloport Port Access System | Surgical Innovations Group PLC | GCJ | Class II | |
| K070543 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | DRG | Class II | |
| K070423 | Tr Band | Terumo Medical Corp. | DXC | Class II | |
| K070208 | Synthes 4.5 Mm Lcp Posterolateral Proximal Femur Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K070052 | Met-Head Model# Mhdd-Xx:cc Diameter, Cc Cannulation | Vilex, Inc. | KWD | Class II | |
| K070041 | Powdered Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and Calibrators | Horiba Instruments Incorporated | MSJ | Class I | |
| K070534 | Modification to: Ocu-Film Tip Cover | Reichert, Inc. | HKY | Class II | |
| K070394 | Cerner Provision Workstation | Cerner Corporation | LLZ | Class II | |
| K070304 | Digora Pct/digipod | Soredex Palodex Group Oy | MUH | Class II | |
| K070232 | ECG Cables, Trunk and Patient Lead Wires | American I.V. Products, Inc. | DSA | Class II | |
| K070138 | Cutera Er:yag Laser Handpiece | Cutera Inc | GEX | Class II |