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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster Inc | DQK | Class II | |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec Inc | HJO | Class II | |
| K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical Inc. | FDI | Class II | |
| K173541 | Epinaut | Imedicom Co., Ltd. | BSO | Class II | |
| K172830 | Double Medical Femoral Nail System | Double Medical Technology Inc. | HSB | Class II | |
| K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | HIH | Class II | |
| K181635 | GMK Sphere CR Tibial Inserts | Medacta International SA | JWH | Class II | |
| K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | FBN | Class II | |
| K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | MYF | Class II | |
| K181333 | ADVIA Centaur Herpes-1 IgG | Biokit, S.A. | MXJ | Class II | |
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | GGZ | Class II | |
| K180173 | Freespira | Palo Alto Health Sciences, Inc. | HCC | Class II | |
| K173890 | GMK Sphere - Kinematic Alignment | Medacta International SA | JWH | Class II | |
| K173784 | Smylic Invisible Clear Aligners | Smylio | NXC | Class II | |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group Ltd. | DFH | Class II | |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter | Cook Incorporated | EZL | Class II | |
| K170050 | Z-CAD smile | Metoxit AG | EIH | Class II | |
| DEN170090 | MATRx plus | Zephyr Sleep Technologies | QCJ | Class II | |
| K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | CAC | Class II | |
| K181312 | GrandioSO x-tra | Voco GmbH | EBF | Class II | |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech | PDQ | Class II | |
| K173024 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | PENTAX of America, Inc. | ODG | Class II | |
| K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | HRX | Class II | |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | |
| K181791 | Simplystrong, Simplyezee | Genicon, Inc. | GCJ | Class II | |
| K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | ODP | Class II | |
| K181400 | H. Pylori Chek™ | Techlab, Inc. | LYR | Class I | |
| K181379 | H. Pylori Quik Chek | Techlab, Inc. | LYR | Class I | |
| K181013 | Fever Scout | Vivalnk, Inc. | FLL | Class II | |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | DSY | Class II | |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Ltd | OMP | Class II | |
| K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | NBW | Class II | |
| K173197 | Reusable NIBP Cuff | Orantech Inc. | DXQ | Class II | |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech(hangzhou)co.,Ltd | NFT | Class II | |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co., Ltd. | NFT | Class II | |
| K180850 | re.t.a Reuseable Tampon Applicator | Thinx, Inc. | HEB | Class II | |
| K171890 | BEXCORE Breast Biopsy System, Biopsy Needle | Medical Park Co., Ltd. | KNW | Class II | |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co 1, LLC. | EKX | Class I | |
| K170824 | BD Vacutainer Eclipse Signal Blood Collection Needle | Becton Dickinson & Co | FMI | Class II | |
| K181983 | PreXion 3D Excelsior | Prexion Corporation | OAS | Class II | |
| K181966 | SmartPerfusion | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. | OWB | Class II | |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | OXC | Class II | |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical Inc | DRY | Class II | |
| K181767 | Cios Select | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | LJE | Unclassified | |
| K181306 | Actifuse Flow | Baxter Healthcare Corporation | MQV | Class II | |
| K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | FRO | Unclassified | |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II |