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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | |
| K250689 | CloudTMS Edge | Teleemg, LLC | OBP | Class II | |
| K251449 | BrainsWay Deep TMS System | Brainsway Ltd. | OBP | Class II | |
| K252595 | Stethophone Pro | Sparrow Acoustics Inc. | DQD | Class II | |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | MXD | Class II | |
| K252586 | Caddie | Odin Medical Limited | QNP | Class II | |
| K252576 | Legend X Platform | Pollogen Ltd | GEI | Class II | |
| K252562 | Spine & Trauma Navigation Instruments | Brainlab, Inc. | OLO | Class II | |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd | NFT | Class II | |
| K252225 | PowerKnot High Strength Sutures | Medacta International SA | GAT | Class II | |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co. Ltd. | OHS | Class II | |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | DYB | Class II | |
| K251843 | Erchonia EVRL | Erchonia Corporation | OLP | Class II | |
| K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K251518 | Volta AF-Xplorer II | Volta Medical | DQK | Class II | |
| K251368 | Fetoly | Diagnoly | IYN | Class II | |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | FBN | Class II | |
| K251083 | Compact II | Enraf-Nonius B.V. | IPF | Class II | |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | LHN | Class II | |
| K250628 | DynaNail TTC Fusion System | Medshape, Inc. | HSB | Class II | |
| K250445 | Fast Warm - NX | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) | Becton Dickinson & Co | ONB | Class II | |
| K250047 | bite away two | Mibetec GmbH | IRT | Class II | |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K243864 | Bonx805 | Bontech Co., Ltd | IZL | Class II | |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | DJG | Class II | |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | LRK | Class II | |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical Ltd | OMP | Class II | |
| K251758 | Serafin® | Tns Co., Ltd. | NXC | Class II | |
| K251399 | SIGNA™ Sprint | GE Healthcare | LNH | Class II | |
| K251320 | Xtra4 | Al.chi.mi.a. SRL | LYX | Unclassified | |
| K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics Ltd | OLO | Class II | |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies Inc. | PDU | Class II | |
| K250797 | UV5000 Handle | Uroviu Corporation | FAJ | Class II | |
| K250507 | Hypertension Notification Feature (HTNF) | Apple Inc. | SFR | Class II | |
| K250216 | OsteoProbe (OP-100) | Active Life Scientific, Inc. | QGQ | Class II | |
| K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | MXA | Class II | |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | LLZ | Class II | |
| K252580 | iQ200 Series | Siemens Healthcare Diagnostics Inc. | LKM | Class II | |
| K252530 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | |
| K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | QJH | Class II | |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Inc. | CBK | Class II | |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus Inc. | LPL | Class II | |
| K250734 | OptiLUV Device | Pollogen Ltd | PBX | Class II | |
| K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | QEB | Class II | |
| K244002 | AngioWaveNet | Angiowave Imaging, Inc. | QIH | Class II | |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | LLZ | Class II | |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics Ltd | ONN | Class II | |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | KPS | Class II |