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 |
|---|---|---|---|---|---|
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 | Hans Biomed Corp. | NEW | Class II | |
| K220407 | Visby Medical Sexual Health Test | Visby Medical, Inc. | QEP | Class II | |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | Rb Health (Us), LLC | NUC | Class II | |
| K230383 | Savvy Surgical Mask - Level 3 | Alg Health, LLC | FXX | Class II | |
| K230315 | Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K223930 | A1417mcw/a1717mcw/f1417mcw | H&abyz | MQB | Class II | |
| K223653 | BD Vaginal Panel | Becton Dickinson & Co | PQA | Class II | |
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | |
| K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | FMF | Class II | |
| K222457 | Provata Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K222445 | LC ChromeFlow | S&C Polymer Silicon- und Composite Spezialitaten GmbH | EBF | Class II | |
| K221621 | Pro-X1™ Trochanteric Nailing System | X-Bolt Orthopedics | HSB | Class II | |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FGB | Class II | |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | MWI | Class II | |
| DEN210033 | Lenire Tinnitus Treatment Device | Neuromod Devices Limited | QVN | Class II | |
| K223452 | Nitronox Scavenger Plus | Parker Hannifin Corp. | CBN | Class II | |
| K230294 | CoverScan (CoverScan v1.1) | Perspectum Ltd. | LLZ | Class II | |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison Rongeur | Morpheus AG | HAE | Class II | |
| K230236 | Lyra Influenza A+B Assay | Ortho-Clinical Diagnostics, Inc. | OZE | Class II | |
| K230060 | Light Based Hair Removal Device GP592 | Shenzhen GSD Tech Co., Ltd | OHT | Class II | |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | KLE | Class II | |
| K223776 | PEEK Spinal Infusion Cage | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | MAX | Class II | |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28 | MBI | Class II | |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik | KNT | Class II | |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | JAK | Class II | |
| K222573 | imani i2Plus Breast Pump | Imani Co. | HGX | Class II | |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | Abbott Medical | QBJ | Class II | |
| K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co.,Ltd. | DXN | Class II | |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | QEP | Class II | |
| K221713 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | FDI | Class II | |
| K221697 | Injection Pin (Kip(02031-02061) (03031-03061)) | Slk Ortho, LLC | NDN | Class II | |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works Inc. | DXC | Class II | |
| K221652 | Nikkicart | Renal Care Dialysis Solutions, S.A. de C.V. | KPO | Class II | |
| K221587 | Dhx-70H, Xtg-70H | Digimed Co., Ltd | EHD | Class II | |
| K221084 | Dyna Locking Trochanteric Nail™ | Innosys Co., Ltd. | HSB | Class II | |
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | DWM | Class II | |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | QHA | Class II | |
| K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | Biosense Webster Inc | MTD | Class II | |
| K230093 | Disposable 4 Layers Surgical Face Mask | Social Medical Supply LLC | FXX | Class II | |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | Echosens | IYO | Class II | |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | OMC | Class II | |
| K223602 | Traumatic brain injury (TBI) test | Abbott Medical | QAT | Class II | |
| K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co.,Ltd. | FMF | Class II | |
| K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | Plasma Concepts | QVJ | Class II | |
| K223436 | Artix AX | Inari Medical, Inc. | QEW | Class II | |
| K223352 | Tenderfoot | Accriva Diagnostics, Inc. | FMK | Class II | |
| K223203 | 1.5T 24E Posterior Array | Shenzhen RF Tech Co., Ltd. | LNH | Class II | |
| K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | QAS | Class II | |
| K222603 | 6F Wallaby Long Sheath | Wallaby Medical | DQY | Class II | |
| K222176 | BoneView | Gleamer | QBS | Class II |