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 |
|---|---|---|---|---|---|
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | Penumbra Inc. | NRY | Class II | |
| K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | FYC | Class II | |
| K203377 | VR101 Lubricating Intravaginal Ring | J3 Bioscience, Inc. | QPD | Class II | |
| K203331 | Quick-20m | CGX, LLC | GWL | Class II | |
| K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting, Ltd. | KCY | Class I | |
| K202899 | Procedure Mask, Surgical Mask | Kenpax International Limited | FXX | Class II | |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | MBF | Class II | |
| K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | KPS | Class II | |
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | |
| K210540 | Ohlendorf Clear Aligner | Ohlendorf Appliance Laboratory | NXC | Class II | |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | FAS | Class II | |
| K210306 | GII Spinal Fixation System | Coligne AG | NKB | Class II | |
| K210237 | Cina Chest | Avicenna.ai | QAS | Class II | |
| K210187 | Overjet Dental Assist | Overjet | LLZ | Class II | |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | JEY | Class II | |
| K202955 | Contour Light CL-100 | Contour Research LLC | OLI | Class II | |
| K202866 | TENS & EMS Device | Shenzhen Jian Feng Electronic Technology Co., Ltd | NUH | Class II | |
| K202593 | Turbett Instrument Pod | TURBETT SURGICAL, Inc | FRG | Class II | |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | PT. Universal Gloves | LYY | Class I | |
| K201569 | CUVIS-spine | CUREXO, Inc. | OLO | Class II | |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer GmbH | JWH | Class II | |
| K210816 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | NKB | Class II | |
| K202709 | Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges | Ningbo Verykind Medical Device Co., Ltd. | GDW | Class II | |
| K202667 | Personal Lubricant Jelly | Nantong Health & Beyond Hygienic Products Inc. | NUC | Class II | |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | LOD | Class II | |
| K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K211105 | Ear-Friendly Mask | Ray Co., Ltd. | FXX | Class II | |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | Zhonghong Pulin Medical Products Co.,Ltd. | LYZ | Class I | |
| K210217 | Needleless Connector | Jiangsu Caina Medical Co., Ltd | FPA | Class II | |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K202793 | Cercare Medical Neurosuite | Cercare Medical a/S | LLZ | Class II | |
| K211130 | NPseal | Guard Medical, Inc. | OKO | Class II | |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | |
| K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Integra Microfrance | GEI | Class II | |
| K210799 | Powder Free Vinyl Patient Examination Gloves | Yunnan Huazhiyuan Medical Technology Co., Ltd. | LYZ | Class I | |
| K210780 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Shandong Shangwei Medical Products Co.,Ltd | LYZ | Class I | |
| K210774 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Shandong Jieshi Medical Products Co.,Ltd | LYZ | Class I | |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | JOW | Class II | |
| K210302 | Disposable Medical mask | Anhui JBH Medical Apparatus Co., Ltd | FXX | Class II | |
| K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock | Set Medikal Sanayi ve Ticaret Anonim Sirketi | FMF | Class II | |
| K210072 | HOLOSCOPE-i | Real View Imaging Ltd. | LLZ | Class II | |
| K203226 | Telescope 0 O 10Mm Wl 305Mm / Telescope 30 O 10Mm Wl 305Mm / Telescope 50 O 10Mm Wl 305Mm, Telescope 0 O 10Mm Wl 440Mm / Telescope 30 O 10Mm Wl 440Mm / Telescope 50 O 10Mm Wl 440Mm | Richard Wolf Medical Instruments Corp. | GCM | Class II | |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | MQL | Class II | |
| K202747 | Klarity Bolus | Klarity Medical & Equipment (GZ) Co., Ltd. | IYE | Class II | |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | DRT | Class II | |
| K200573 | BoneTrust Mini Implant System | Medical Instinct Deutschland GmbH | DZE | Class II | |
| K211118 | Signa 7.0T | GE Healthcare | LNH | Class II | |
| K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | |
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International SA | JWH | Class II |