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 |
|---|---|---|---|---|---|
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular Inc | DQY | Class II | |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | |
| K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge to Life Ltd | KDN | Class II | |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | SCA | Class II | |
| K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | KL-Kepong Rubber Products Sdn. Bhd. | LZA | Class I | |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | DXH | Class II | |
| DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | Tissium SA | SFD | Class II | |
| DEN240038 | Oxiplex® | Fziomed, Inc. | QVL | Class II | |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K250900 | EvoEndo Single-Use Endoscopy System | Evoendo, Inc. | FDS | Class II | |
| K250685 | Methinks NCCT Stroke | Methinks Software, S.L | QAS | Class II | |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | LNH | Class II | |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance Ltd. | LNH | Class II | |
| K244012 | Mosaic (V1.0.1) | Navier Medical | LLZ | Class II | |
| K243872 | BD Veritor System for SARS-CoV-2 | Becton Dickinson & Co | QVF | Class II | |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co,Ltd | EZL | Class II | |
| K242978 | Geo Abutment | Geomedi Co., Ltd. | NHA | Class II | |
| K242870 | Access hsTnI | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) | Bestway Plastic and Metal Products Ltd. | OHT | Class II | |
| K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. Ltd. | LDF | Class II | |
| K240795 | Withings ECG App | Withings | QDA | Class II | |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc | QEW | Class II | |
| K251189 | Aventus Thrombectomy System | Inquis Medical, Inc. | QEW | Class II | |
| K251166 | Mfinity Femoral System | Medacta International SA | MEH | Class II | |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd | NGX | Class II | |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | NAY | Class II | |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc | ITX | Class II | |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | QVF | Class II | |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | HWC | Class II | |
| K250075 | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | DQX | Class II | |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | FUJIFILM Corporation | EOQ | Class II | |
| K243729 | Prismira | Lumos Labs, Inc. | QFT | Class II | |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Terumo Cardiovascular Systems Corporation | JCX | Class II | |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Brainlab, Inc. | QIH | Class II | |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH | ETN | Class II | |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | FTL | Class II | |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine LLC | OVD | Class II | |
| K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corp. | BTG | Class II | |
| K251209 | Medical Monitor (32HS710S) | LG Electronics.Inc | GCJ | Class II | |
| K251193 | Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft | Medtronic Sofamor Danek | MQV | Class II | |
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments | Ht Medical D.B.A. Xenix Medical | NKB | Class II | |
| K251153 | Aurora | GE Medical Systems, Israel Ltd. | KPS | Class II | |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co, Ltd. | GEX | Class II | |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K250826 | Multi M Series | DMAX Co., Ltd. | EIH | Class II | |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | |
| K250782 | Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd | GEX | Class II | |
| K250559 | GMReis Fibula Nail System | Gm dos Reis Industria E Comercio | HSB | Class II |