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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) | Medos International SARL | OLO | Class II | |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | OVD | Class II | |
| K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co. Ltd. | GXY | Class II | |
| K221627 | PerfusionGo Plus | Yukun (Beijing) Technology Co., Ltd. | LLZ | Class II | |
| K221522 | HF-cables (resusable) | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | PDU | Class II | |
| K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co.,Ltd | GXY | Class II | |
| K220059 | Biosci™ Inactivated Transport Medium, Biosci™ ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | QBD | Class II | |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | LNS | Class II | |
| K213175 | No Stress Impress | No Stress Impress, LLC | ELW | Class II | |
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | GDW | Class II | |
| K223819 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | OUR | Class II | |
| K223804 | PercuNav Image Fusion and Interventional Navigation System | Philips North America LLC | JAK | Class II | |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies Limited | QNO | Class II | |
| K223107 | Molli 2 | Molli Surgical, Inc. | NEU | Class II | |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging Inc | LLZ | Class II | |
| K222000 | Transit-Pellets | Medifactia AB | FFX | Class II | |
| K221726 | Uni-FuZe-C Bone Strip | Zavation Medical Products, LLC | MQV | Class II | |
| K221088 | Anatomic Bone Plate | Double Medical Technology Inc. | HRS | Class II | |
| K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | GCJ | Class II | |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | LON | Class II | |
| K223800 | MIM – Additional Tracers | MIM Software Inc | LLZ | Class II | |
| K223795 | FairFix QT Adjustable Button | Medacta International SA | MBI | Class II | |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS | Class II | |
| K223222 | Plasma IQ | Neauvia North America, Inc | GEI | Class II | |
| K223010 | Portable X-ray System | Iray Technology Taicang, Ltd. | EHD | Class II | |
| K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | IYE | Class II | |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K220884 | Disposable Endoscope Valve Sets | SML Med-Tech Solutions Limited | ODC | Class II | |
| K220649 | Elucis | Realize Medical Inc. | LLZ | Class II | |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek LLC | IPF | Class II | |
| K223748 | Nitrile Exam Gloves (Chemotherapy Drug Tested) | US Medical Glove Company | LZA | Class I | |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console | ZOLL Circulation, Inc. | NCX | Class II | |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | LLZ | Class II | |
| K223480 | Medipoint Blood Lancets | MEDIPOINT Holdings, LLC | QRK | Class II | |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K Biomed Co.,Ltd. | MAX | Class II | |
| K223429 | Contour Knee | Quality Electrodynamics | MOS | Class II | |
| K223405 | Access Testosterone | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K223221 | Non-Sterile Powder Free Nitrile Examination Gloves | Dynacare Sdn Bhd | LZA | Class I | |
| K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | HBI | Class II | |
| K223031 | Vibrant System | Vibrant Ltd | QTN | Class II | |
| K222913 | s-Clean Link Abutment | Dentis Co.,Ltd | NHA | Class II | |
| K222782 | Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) | Zhejiang Carebao Co., Ltd. | HGX | Class II | |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Inc. | OBP | Class II | |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | NIE | Class II | |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | GXP | Class II | |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | FXX | Class II | |
| K221542 | Galileo Vertebral Body Replacement Device | Bright Spine | PLR | Class II | |
| K221317 | S-Mono | Shinhung MST Co., Ltd. | DZE | Class II |