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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Medical | QLG | Class II | |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | OWN | Class II | |
| K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | Arthrex GmbH | KNW | Class II | |
| K213090 | Frontier Series Power Wheelchairs | Magic Mobility | ITI | Class II | |
| K212697 | Leaf Smooth | Shenzhen Leaflife Technology Co., Ltd. | OHT | Class II | |
| K212673 | Mr 5300 | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K212661 | Disposable Nitrile Examination Glove | Inner Mongolia Cureguard Medical Technology Co., Ltd. | LZA | Class I | |
| K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K212015 | BD Nano 2nd Gen Pen Needle | Becton Dickinson & Co | FMI | Class II | |
| K211326 | EndoScreener | Chengdu Wision Medical Device Co., Ltd. | QNP | Class II | |
| K211080 | EkoSonic Endovascular Device | Boston Scientific Corporation | QEY | Class II | |
| K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | O&M Halyard, Inc. | LZA | Class I | |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma Ltd. | KOD | Class II | |
| K210831 | OnQ Neuro | Cortechs Labs, Inc. | QIH | Class II | |
| K210573 | Velofix SA Cervical Cage | CG MedTech Co., Ltd. | OVE | Class II | |
| K203074 | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) | PT. Universal Gloves | LYY | Class I | |
| K202288 | Finebeam | SNJ Co., Ltd. | GEX | Class II | |
| K213469 | Valory | Agfa N.V. | MQB | Class II | |
| K213406 | Savvy Mask - Level 3 Surgical Face Mask | Texas Medplast, LLC | FXX | Class II | |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co Ltd | ESW | Class II | |
| K213070 | MD-320W Ultrasound Biomicroscope | Meda Co., Ltd. | IYO | Class II | |
| K213041 | IPL Hair Removal, Model: OBT-02 | Glan Electronics Co., Ltd. | OHT | Class II | |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | PHX | Class II | |
| K212640 | Stratum® Ankle Fusion Plating System | Medartis AG | HRS | Class II | |
| K212600 | Disposable Medical Nitrile Examination Gloves (Non-sterile) | Suqian Linglian Medical Technology Co., Ltd. | LZA | Class I | |
| K212487 | CoLink Vallux Plating System | In2bones USA, LLC | HRS | Class II | |
| K212275 | Dermalux Flex MD | Aesthetic Technology Ltd | OHS | Class II | |
| K212112 | Cardiologs Holter Platform | Cardiologs Technologies | DPS | Class II | |
| K212104 | Water-soluble Personal Lubricant | Foshan Pingchuang Medical Technology Co., Ltd | NUC | Class II | |
| K212046 | Impertech Surgical Face Mask | Impertech Industries, Ltd. | FXX | Class II | |
| K212000 | Medley | Good Clean Love, Inc. | NUC | Class II | |
| K211998 | Desnuda Reflect | Good Clean Love, Inc. | NUC | Class II | |
| K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | JOW | Class II | |
| K211871 | FAICO Dental Implant System and CAD/CAM Abutments | Faico Medical, LLC | NHA | Class II | |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC. | NLG | Class II | |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical | NVK | Class II | |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | GZL | Class II | |
| K200091 | Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation | KFM | Class II | |
| K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc | LNH | Class II | |
| K212444 | Qora Stool Management Kit | CM Technologies, Inc. | KNT | Class II | |
| K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | Arthrex GmbH | PHX | Class II | |
| K212336 | Soteria.AI | Omega Medical Imaging, LLC | OWB | Class II | |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co.,Ltd. | MMK | Class II | |
| K211678 | Lunit INSIGHT MMG | Lunit Inc. | QDQ | Class II | |
| K211538 | Protect X Level 3 Isolation Gown | AZAC Group | FYC | Class II | |
| K210042 | Disposable Surgical Mask | Suzhou Letian Protective Products Co., Ltd. | FXX | Class II | |
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International SA | HSX | Class II | |
| K212996 | Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc | HWC | Class II |