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 |
|---|---|---|---|---|---|
| K252070 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | OMB | Class II | |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | LLZ | Class II | |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | QLY | Class II | |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co. Ltd | CAW | Class II | |
| K251506 | Nelli (Version 7.11) | Neuro Event Labs Oy | POS | Class II | |
| K251293 | CardioVision | Icardio.Ai | QUO | Class II | |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona Inc | NHA | Class II | |
| K250714 | FluoroDose Varnish | Centrix, Inc. | LBH | Class II | |
| K250700 | Pen Injector Needle 32.5 | Terumo Corp. | FMI | Class II | |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | DeRoyal Industries, Inc. | OMP | Class II | |
| K250560 | Bee Ha | Ngmedical GmbH | ODP | Class II | |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | LLZ | Class II | |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | EBI | Class II | |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K253123 | CuRAS hybrid | Classys Inc | GEX | Class II | |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | JTN | Class II | |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | MEDLINE INDUSTRIES, LP - Northfield | DXC | Class II | |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. dba Consensus Orthopedics | LPH | Class II | |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions LLC | KTT | Class II | |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Remington Medical | DPW | Class II | |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance Ltd. | LNH | Class II | |
| K251365 | OptumSI Implant System | SI Solutions | OUR | Class II | |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | MUJ | Class II | |
| K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | FZP | Class II | |
| K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems Inc | OZZ | Class II | |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | GCJ | Class II | |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | JWH | Class II | |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | Sunglor Technology Co.,Ltd | OHS | Class II | |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'an Yeolight Smart Electronics Co.,Ltd | OHT | Class II | |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations | HRS | Class II | |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) | Shenzhen Dachi Communication Co.,Ltd. | OHS | Class II | |
| K251910 | Focal One® | Edap Technomed Inc. | PLP | Class II | |
| K250912 | IntelliSep Test | Cytovale, Inc. | QUT | Class II | |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | Fisher & Paykel Healthcare, Inc. | SGR | Class II | |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K242603 | MyPAO SA guides | Medacta International SA | PBF | Class II | |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc | HRS | Class II | |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & Co. KG | FGB | Class II | |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | QRX | Class II | |
| K252729 | Universal Spinal System | Double Medical Technology Inc. | NKB | Class II | |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | LGZ | Class II | |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | Guangzhou Wondfo Biotech Co., Ltd. | NFT | Class II | |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex, Ltd. | HIS | Class II | |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies Inc | DQA | Class II | |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies Inc | DQA | Class II |