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 |
|---|---|---|---|---|---|
| K030272 | Flat Panel Display, Me183l | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K030233 | Travelsome Standard | Sim Italia S.r.l. | CAW | Class II | |
| K022294 | Apneacheck | Im Systems | MNR | Class II | |
| K031090 | Modification to Xia Stainless Steel System | Howmedica Osteonics Corp | KWP | Class II | |
| K031087 | Edwards Introducer Sheath | Edwards Lifesciences LLC | DYB | Class II | |
| K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross Angled Support Catheter, Safe Crot | Intra Luminal Therapeutics, Inc. | DQY | Class II | |
| K030979 | Modification to Depuy Solution System Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K030971 | Modification to Modular Plus Revision Stem | Plus Orthopedics | LWJ | Class II | |
| K030879 | Veritas Collagen Matrix | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | OXE | Class II | |
| K030779 | 5F Medtronic Launcher Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K030764 | Z-Box | Z-Kat, Inc. | HAW | Class II | |
| K030715 | Saffron Nm Guiding Catheter | Neich Medical (Shenzhen) Company Limited | DQY | Class II | |
| K030681 | Quanta Plex Ena Profile 5 | Inova Diagnostics, Inc. | LLL | Class II | |
| K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | KWQ | Class II | |
| K030568 | Radii | Southern Dental Industries, Inc. | EBZ | Class II | |
| K030541 | Hl888jf | Health & Life Corporation | DXN | Class II | |
| K030461 | A127 Lead Extension | Abbott Medical | GZB | Class II | |
| K030404 | C. Difficile Tox A/b II | Techlab, Inc. | LLH | Class I | |
| K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Inc. | HWC | Class II | |
| K030261 | Battery, Rechargeable | Access Battery, Inc. | HGM | Class II | |
| K030259 | Amatomical Shoulder with Removable Head | Centerplus Orthopedics, Inc. | KWS | Class II | |
| K023676 | Applanation Tonometer | Optilasa, S.L. | HKX | Class II | |
| K023205 | Elox P 45-Bp; Elox P 53-Bp; Elox P 60-Bp | BIOTRONIK AG | DTB | Class III | |
| K031091 | Vti 20 Mhz Gated Doppler | Vascular Technology Incorporated | DPW | Class II | |
| K030937 | Stimucath Continuous Nerve Block Set, Models Ab-02030, Ab-02060, Ab-02090, Ab-02030-Pk, Ab-02060-Pk, Ab-02090-Pk | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | Class II | |
| K030906 | Axcel Surgical Light | Alm S.A. | FSY | Class II | |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314 | Imtec Corp. | DZE | Class II | |
| K030235 | F1 Diode Laser System | Opus Medical, Inc. | GEX | Class II | |
| K024342 | Radiographic Film Processor, Models Xp400 and Xp1000 | Daito Co., Ltd. | IXW | Class II | |
| K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and Accessories | GE Healthcare | CCK | Class II | |
| K023256 | Precision Xtra/medisense Optium/precision Easy/medisense Optium Easy Blood Glucose Test Strip with True Measure Technolo | Abbott Medical | NBW | Class II | |
| K030943 | Modification to Hiox | Sensor Medics Corp. | CBP | Class II | |
| K030556 | Steelex Electrode Set | Aesculap Inc | LDF | Class II | |
| K030310 | Synthes Stainless Steel Modular Hand System | Synthes (USA) Products LLC | HRS | Class II | |
| K030283 | Baby Pod | Prism Enterprises, Inc. | FPP | Class I | |
| K030129 | Modification to Ensite 3000 System, Model Ee3000 | Endocardial Solutions, Inc. | DQK | Class II | |
| K030056 | Worry-Remover Irrigator | Corisen Group, Ltd. | HED | Class I | |
| K024117 | Insorb Absorbable Staples, Model Sp-B20 | Incisive Surgical, Inc. | GDW | Class II | |
| K023623 | Novavision, Model 2.0 | Novavision, Inc. | HPT | Class I | |
| K023553 | Mastergraft Matrix | Medtronic Sofamor Danek | MQV | Class II | |
| K021939 | Vitalcare Foley Catheter | Vitalcare, Inc. | EZL | Class II | |
| K021938 | Vitalcare Urethral Catheter | Vitalcare, Inc. | GBM | Class II | |
| K030967 | Rita Starburst Sde Electrosurgical Device | Boston Scientific Corporation | GEI | Class II | |
| K030809 | Hanson Medical Gluteal Implant | Hanson Medical, Inc. | MIB | Class II | |
| K030808 | Hanson Medical Calf Implant | Hanson Medical, Inc. | MIB | Class II | |
| K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | FTM | Class II | |
| K030704 | Ibd-Quik Chek | Techlab, Inc. | DEG | Class I | |
| K030606 | Coulter Lh 750 Body Fluids Application | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K030334 | T-Scientific T-Pad | T-Scientific, Inc. | QSY | Unclassified | |
| K030203 | Long Well Lw-6Dxx Series Body Fat Analyzer | Long Well Electronics Corp. | MNW | Class II |