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 |
|---|---|---|---|---|---|
| K090505 | Speq Ultrasound System | Signostics Limited | IYO | Class II | |
| K090428 | Ats Simulus Adjustable Flexible Annuloplasty, Model 735 Ac | Genesee BioMedical, Inc. | KRH | Class II | |
| K090365 | Hansen Medical Artisan S Control Catheter | Hansen Medical, Inc. | DXX | Class II | |
| K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | NHA | Class II | |
| K082834 | Ellman International Non-Ablative Technique for Surgitron Iec | Ellman Intl., Inc. | GEI | Class II | |
| K082497 | Intuitive Surgical Endowrist One Hot Shears Instrument | Intuitive Surgical, Inc. | NAY | Class II | |
| K082134 | Circulator Boot | Circulator Boot Corp. | DRN | Class II | |
| K081138 | Safeflo Vena Cava Filter | Rmt Medical Technilogies, Inc. | DTK | Class II | |
| K091267 | Vonflex Putty | Vericom Co., Ltd. | ELW | Class II | |
| K090994 | Ligafix Interface Screw | Science for Biomaterials | HWC | Class II | |
| K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | FTL | Class II | |
| K090490 | Mirage Echo | ResMed Corp | BZD | Class II | |
| K090486 | Asthma Monitor Model, Am1 | Cardinal Health Germany 234 GmbH | BZG | Class II | |
| K090385 | Lariat II Suture Delivery Device | Sentreheart, Inc. | GAT | Class II | |
| K090335 | Hd Guide Catheter | Concentric Medical, Inc. | DQY | Class II | |
| K090266 | Matchedflicker | Eyeic Corporation | NFJ | Class II | |
| K090042 | Painmaster Mct Patch | Newmark, Inc. | NUH | Class II | |
| K090033 | Modification to: Pss System | Spinal USA | MNI | Class II | |
| K083922 | Micrus Microcatheter, Courier Flex, Model Msf 170000-00 | Micrus Endovascular Corporation | DQO | Class II | |
| K083822 | Laser Touchone | Laser Health Technologies | GZJ | Class II | |
| K083289 | Human Beta-2 Microglobulin Kit | The Binding Site | JZG | Class II | |
| K081640 | Gimmi Aneurysm Clips and Applying Forceps | Gimmi GmbH | HCH | Class II | |
| K072288 | Pathfast D-Dimer | Mitsubishi Kagaku Iatron | GHH | Class II | |
| K091172 | Nio 2Mp (Mdng-2121) | Barco N.V. | LLZ | Class II | |
| K091164 | Ge Venue 40, Model 5324338 | GE Medical Systems China Co., Ltd. | IYN | Class II | |
| K091160 | Lungpoint Virtual Bronchoscopic Navigation Vbn System | Broncus Technologies, Inc. | LLZ | Class II | |
| K091139 | Conmed Aer Defense Smoke Evacuator | ConMed Corporation | FYD | Class II | |
| K090311 | Elecsys Rubella Igg Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K090288 | Orthadapt Pr | Pegasus Biologics, Inc. | FTL | Class II | |
| K083502 | Panther Realart, Model 4.7 | Prowess, Inc. | MUJ | Class II | |
| K083480 | Inclusive Zirconia Abutment Blanks | Inclusive Dental Solutions | NHA | Class II | |
| K083291 | Cirrus Hd-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000 | Carl Zeiss Meditec Inc | OBO | Class II | |
| K082612 | Gbs Pna Fish | Advandx, Inc. | OAH | Class I | |
| K091016 | Covidien Sports Surgery as Meniscal Repair Device with High Strength Suture | Surgical Devices, A Global Business Unit Covidien | GAT | Class II | |
| K090913 | Cross-Pilot Turbo Elite Support Catheter | Spectranetics Corp. | DQY | Class II | |
| K090559 | Footprint Medical Silicone Feeding Tube | Footprint Medical Inc. | KNT | Class II | |
| K090360 | Philips M3001a Multi Measurement Server | Philips Medizin Systeme Boblingen GmbH | DQA | Class II | |
| K090182 | Module Integrated Radiotherapy System (Mirs) | Nuclemed S.A. | MUJ | Class II | |
| K090157 | Isolyser Home Sharps Management (Hsm), Model 800M; Isoly Sharps Management System (Sms), Models 2400M, 4000M, 10000M, 5. | WCM Waste & Compliance Management, Inc. | MMK | Class II | |
| K090024 | Tgs Unicompartmental Knee Arthroplasty System | Alexandria Research Technologies, LLC | HSX | Class II | |
| K083733 | Lume 2 System, Model Ga0005000 | Lumenis Ltd | GEX | Class II | |
| K091146 | Modification to Cyberknife Robotic Radiosurgery System | Accuray Incorporated | MUJ | Class II | |
| K091114 | Txrx 1.5T Cp Head Coil; Txrx 3T Cp Head Coil | Quality Electrodynamics | MOS | Class II | |
| K091107 | Model P8400 Hemostatix Thermal Scalpel System | Hemostatix Medical Technologies, LLC | GEI | Class II | |
| K090973 | Terumo Surshield Safety i.v. Catheter (18G X 51Mm & 20G X 51Mm Sizes) | Terumo Corp. | FOZ | Class II | |
| K090870 | Echelon Micro Catheter, Models 105-5092-150Sa, 145-5092-150Sa and 190-5092-150Sa and Syringe Adapter Accessory | Medtronic, Inc. | KRA | Class II | |
| K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models Ab14w020210090, Ab14w020210150 | Medtronic, Inc. | DQY | Class II | |
| K090684 | Avante Leucite Blocks | Somerset Dental Products, Inc. | EIH | Class II | |
| K090371 | Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System | STERIS Corporation | KCT | Class II | |
| K090308 | Restep Dvy System, Model Rsp-101 | Stortford Medical, LLC | JOW | Class II |