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 |
|---|---|---|---|---|---|
| K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | QUQ | Class II | |
| DEN230035 | DentalMonitoring | Dental Monitoring SAS | SBC | Class II | |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | KNT | Class II | |
| K240752 | Deka Toro | El.En S.p.A. | GEX | Class II | |
| K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | Thermo Fisher Scientific Oy | JWY | Class II | |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | Shanghai Bele Medical Technology Co.,Ltd | GEX | Class II | |
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies Limited | QNO | Class II | |
| K240059 | FAgamin® | Tedequim SRL | PHR | Class II | |
| K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co.,Ltd. | IYN | Class II | |
| K233625 | Raydent Sw | Ray Co., Ltd. | PNN | Class II | |
| K233473 | Deka Lotus | El.En S.p.A. | ONF | Class II | |
| K233137 | Ticare Dental Implant Systems | Mozograu S.A. | DZE | Class II | |
| K232933 | AirKEE P900 | Healkee Medical Pte. Ltd. | FRA | Class II | |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | Owens & Minor (O&M) Halyard, Inc. | FYC | Class II | |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | IPF | Class II | |
| K232542 | Wedge XL Delivery Catheter | Terumo Cardiovascular Systems Corporation | QJP | Class II | |
| K232495 | Sempulse Halo Vital Signs Monitor | Sempulse Corporation | DQA | Class II | |
| K230711 | Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd | NGX | Class II | |
| K241112 | BriefCase-Quantification | Aidoc Medical Ltd. | QIH | Class II | |
| K241053 | MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL | Medtronic Cardiac Surgery | DTN | Class II | |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | HKI | Class II | |
| K241043 | Augment Off-Axis Instrument System | Fix Surgical | PHX | Class II | |
| K240368 | E3D™-A Interbody System | Evolution Spine, LLC | OVD | Class II | |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | PHX | Class II | |
| K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin Oy | OLX | Class II | |
| K233247 | Heuron ICH | Heuron Co., Ltd. | QAS | Class II | |
| K231940 | BruxZir® NOW SRC | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision Ltd. | SAX | Class II | |
| K240426 | Aventus Clot Management System | Inquis Medical, Inc. | CAC | Class II | |
| K233913 | Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) | Aoj Health Technology Co., Ltd. | HGX | Class II | |
| K232662 | BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics NLE | DQX | Class II | |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific LLC | NGL | Class II | |
| K240759 | Remex-Gr100 | Remedi Inc. | EHD | Class II | |
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co.,Ltd | PKT | Class II | |
| K233875 | Brainomix 360 e-Lung | Brainomix Limited | JAK | Class II | |
| K232862 | MIM – Monte Carlo Dosimetry | MIM Software Inc | LLZ | Class II | |
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | SRI Trang Gloves (Thailand) Public Company Limited. | LZA | Class I | |
| K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | CBI | Class II | |
| K232242 | BEAR 2 Body | Foreo Inc | NFO | Class II | |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co.,Ltd. | HEB | Class II | |
| K240699 | SCARLET® AC-Ti | Spineart SA | OVE | Class II | |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | DJG | Class II | |
| K240479 | Access OV Monitor | Siemens Healthcare Diagnostics Inc. | LTK | Class II | |
| K240374 | Ureterorenoscope System | Shenzhen Hugemed Medical Technical Development Co., Ltd | FGB | Class II | |
| K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | KIF | Class II | |
| K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) | NEZ | Class II | |
| K234079 | HyperSuture Extension Line | Threadstone LLC | GAT | Class II | |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | LNH | Class II |