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 |
|---|---|---|---|---|---|
| K082707 | Medx Lpt 200 Tethered Laser & Medx Lps 200 (Oralase) Portable Laser | Medx Electronics, Inc. | ILY | Class II | |
| K082510 | Image-Arena Applications, Model Image-Arena Va Platform 1.0, 4D Lv-Analysis 2.5, 4D Lv-Analysis Mr 1.0 | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K082331 | Magnetom C! | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K082238 | Neomed Polyurethane Feeding Tube | Halyard Health | FPD | Class II | |
| K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model Om-6500 | ArthroCare Corporation | HWC | Class II | |
| K081572 | Smartsigns Minpulse | Huntleigh Healthcare Ltd. | DQA | Class II | |
| K073022 | Clareblend LED Probes Model# 7201-415, 7204-631, 7205-830 | Clareblend, Inc. | GEX | Class II | |
| K073000 | Lumaprobe | Clareblend, Inc. | GEX | Class II | |
| K082656 | Model Ff Sonic US-750 Xt Diagnostic Ultrasound System 3D Imaging Unit | Fukuda Denshi USA, Inc. | IYN | Class II | |
| K082571 | Avaulta Support System | C.R. Bard Inc | OTP | Class III | |
| K082562 | Applied Biosystems 7500 Fast Dx | Applied Biosystems | NSU | Class II | |
| K082444 | Disposable Vinyl Examination Glove, Powdered | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K082364 | Imagenet Professional Pc Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for | Topcon Corp. | NFJ | Class II | |
| K082159 | Civastring Pd-103 | CivaTech Oncology Inc. | KXK | Class II | |
| K082047 | Securacath Catheter, Model Spk01 | Interrad Medical Inc | OKC | Class II | |
| K081782 | Collieva | Innocoll Pharmaceuticals | KGN | Unclassified | |
| K081749 | Avante Z Zirconia (As)3 Blocks | Pentron Ceramics, Inc. | EIH | Class II | |
| K081658 | Powder-Free Vinyl Examination Gloves | Jiangsu Alfa Glove Co., Ltd. | LYZ | Class I | |
| K081448 | Encore Shoulder Revision Glenoid | Encore Medical, LP | MBF | Class II | |
| K081425 | Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port | Cook Vandergrift, Inc. | LJT | Class II | |
| K080570 | Cdc Human Influenza Virus Real-Time Rt- PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | NXD | Class II | |
| K082752 | Quickpin | Laboratorios Grifols, S.A. | LHI | Class II | |
| K082140 | Xpert Mrsa/sa Blood Culture Assay | Cepheid | NQX | Class II | |
| K081871 | Universal Electrodes | Neurometrix, Inc. | GXY | Class II | |
| K081865 | Proclear Multifocal Toric and Xr and Toric Xr | CooperVision, Inc. | LPL | Class II | |
| K081777 | Ventrio Hernia Patch | C.R. Bard Inc | FTL | Class II | |
| K081553 | AED Bipolar Forceps, Model 13-1646 | National Advanced Endoscopy Devices, Inc. | GEI | Class II | |
| K082685 | Galaxy 55 | Larsen & Toubro Limited | MWI | Class II | |
| K082616 | Haselmeier Pen 8 | Haselmeier GmbH | FMF | Class II | |
| K082524 | Mini Ghost, Model: 507 | Numed Inc | DQY | Class II | |
| K082523 | Osstell Isq Implant Stability Meter | Osstell AB | EKX | Class I | |
| K082519 | Finecross Mg Coronary Micro-Guide Catheter | Terumo Medical Corp. | KRA | Class II | |
| K082469 | United U2 Patella | United Orthopedic Corp. | JWH | Class II | |
| K082443 | Disposable Synthetic Examination Gloves, Powder Free | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K082366 | Lifebed Patient Vigilance System | Hoana Medical, Inc. | DRT | Class II | |
| K082317 | Ge Lunar Frax 10-Year Fracture Risk Software Option | General Electric Co. | KGI | Class II | |
| K082256 | Life Support for Trauma and Trnsport (Lstat) G6 Lite | Integrated Medical Systems Inc | MWI | Class II | |
| K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Co., Ltd | EHD | Class II | |
| K082037 | Seeplate Cervical Plate System | Amedica Corp. | KWQ | Class II | |
| K082029 | Synthetic Powder Free (Pink) Vinyl Patient Examination Glove | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K082004 | Smoothkit+ | Osyris | GEX | Class II | |
| K081989 | Modification to Fetch Aspiration Catheter | Possis Medical, Inc. | QEZ | Class II | |
| K081987 | Unisyn Image Fusion, Version 1.0 | Convergent Imaging Solutions | LLZ | Class II | |
| K081860 | Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments | Zimmer GmbH | LZO | Class II | |
| K081808 | Acunav V Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | |
| K081625 | Flowpicc Stylet | Teleflex Medical | OBJ | Class II | |
| K081539 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33 | Abbott Medical | DLZ | Class II | |
| K080948 | Hd Endoeye Laparo-Thoraco Videoscope Olympus Ltf Type Vh | Olympus Medical Systems Corp. | HET | Class II | |
| K080933 | Handheld ECG Monitor, Model Md100 | Beijing Choice Electronic Technololgy Co., Ltd. | DPS | Class II |