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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K952219 | Suction Tip Cleaner Cup | Moore/Gobel | GCX | Class II | |
| K946345 | Integral VIII Biointegrated Dental Implant System | Calcitek, Inc. | DZE | Class II | |
| K946319 | Integral VII 4.9Mm Biointegrated Dental Implant System | Calcitek, Inc. | DZE | Class II | |
| K944352 | Smartdose III Infusion Container | River Medical, Inc. | FRN | Class II | |
| K944351 | Smartdose IV Prefilled Infusion Container | River Medical, Inc. | FRN | Class II | |
| K943449 | Neurological Diagnostic Devices | Henley Intl. | GXY | Class II | |
| K942855 | Non-Chlorinated Powder Free Latex Examination Gloves | Evergrade Healthcare Products Sdn Bhd | LYY | Class I | |
| K935767 | Sims Silo Needle De-Access Enclosure | Sims Deltec, Inc. | LJT | Class II | |
| K955043 | Welch Allyn Bi-Otoscope | Welch Allyn Inc | ERA | Class I | |
| K954919 | Merocel Soft Wound Dressing | Merocel Corp. | KMF | Class I | |
| K954857 | Comfeel:alginate Filler | MEDLINE INDUSTRIES, LP - Northfield | KMF | Class I | |
| K954851 | Biopolar Forceps Line | Johnson & Johnson Professionals, Inc. | GEI | Class II | |
| K954734 | The Tulip Lci-200 Illumination & Imaging System (Modification) | The Tulip Mfg. Co. | FET | Class II | |
| K954510 | Rriangle Knife | Phx Technologies Corp. | HRX | Class II | |
| K954509 | Probe Knife | Phx Technologies Corp. | HRX | Class II | |
| K954508 | Retractor | Phx Technologies Corp. | HRX | Class II | |
| K954507 | Retrograde Knife | Phx Technologies Corp. | HRX | Class II | |
| K954449 | ENT Packings, Wicks, Wipes, and Sponges | Oasis | LYA | Class I | |
| K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | LNH | Class II | |
| K954225 | Med-Tec Hand Grip | Medtec LLC | IXQ | Class II | |
| K954127 | Biofeedback Device | Verimed Holdings, Inc. | HCC | Class II | |
| K954106 | Theratest Lab, Inc., El-Anascr Kit | Theratest Laboratories, Inc. | LJM | Class II | |
| K953883 | Access Low Level Ige Controls | Bio-Rad Laboratories Inc. | JJX | Class I | |
| K953794 | Sharplan Lasers, Inc. Surgical Diode Laser | Sharplan Lasers, Inc. | GEX | Class II | |
| K953780 | Access Allergen Dog Epithelim | Bio-Rad Laboratories Inc. | DHB | Class II | |
| K953621 | Evt-3300 | U.S. Table, Inc. | INQ | Class I | |
| K953362 | Premier Ehec | Meridian Diagnostics, Inc. | GNA | Class I | |
| K953095 | Philips Easyvision | Philips North America LLC | LLZ | Class II | |
| K952958 | The Tulip Company Branson Oversheath | The Tulip Mfg. Co. | GCJ | Class II | |
| K952953 | The Tulip Cxompany Branson #2 Elevator | The Tulip Mfg. Co. | GCJ | Class II | |
| K952951 | The Tulip Company Brason Nerve Hook & Dissector | The Tulip Mfg. Co. | GCJ | Class II | |
| K952932 | The Tulip Company Branson #1 Elevator | The Tulip Mfg. Co. | GCJ | Class II | |
| K952902 | The Tulip Company Branson Posterior Dissector | The Tulip Mfg. Co. | GCJ | Class II | |
| K952901 | The Tulip Company Branson #1 & #2 Elevator | The Tulip Mfg. Co. | GCJ | Class II | |
| K952898 | Gore-Tex Sam Facial Implant with Introducer | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K952682 | Lokki Dt | Lokki | GEX | Class II | |
| K952565 | Lyofoam Extra | Acme United Corp. | KMF | Class I | |
| K952063 | Xxl Ballon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K951723 | Ge B510 Transducer | GE Healthcare | ITX | Class II | |
| K951685 | Auraflex Testosterone Calibrator Pack | bioMerieux, Inc. | CDZ | Class I | |
| K951650 | Clinical Proton Spectroscopy Option | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K950475 | Disposable ECG Monitoring Electrode #4530, #4540 | Nikomed U.S.A., Inc. | DRX | Class II | |
| K950472 | Disposable ECG Monitoring Electrode #4110 45Mm, #4140 35Mm | Nikomed U.S.A., Inc. | DRX | Class II | |
| K945578 | Nihon Kohden Zb-821 Telemetry Transmitter | Nihon Kohden America Inc | DRG | Class II | |
| K945376 | Doc's Proplugs Ear Plugs | Doc'S Proplugs, Inc. | EWD | Unclassified | |
| K940001 | Plato-Srs(stereo Radiosurgery Treatment Planning Sys) | Nucletron BV | IYE | Class II | |
| K933878 | Zymmune(tm) Cd4/cd8 Cell Monitoring Kit | Intracel Corp. | GKZ | Class II | |
| K954937 | Coast Hearing Chs (Custom Hearing System) | Coast Hearing Services | ESD | Class I | |
| K954794 | Oticon | Oticon, Inc. | ESD | Class I | |
| K954569 | Immulite Theophylline | Siemens Healthcare Diagnostics Inc. | KLS | Class II |