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 |
|---|---|---|---|---|---|
| K242890 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | |
| K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | BSK | Class II | |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | NPM | Class II | |
| K242383 | Apex Locator | Shenzhen Rogin Medical Co., Ltd | LQY | Unclassified | |
| K242338 | Cleerly LABS (v2.0) | Cleerly, Inc | QIH | Class II | |
| K242207 | Noable Laser | Daeju Meditech Engineering Co., Ltd. | GEX | Class II | |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG | BTA | Class II | |
| K241159 | Handbike Batec Electric | Batec Mobility S.L | ITI | Class II | |
| K250344 | BD Phoenix™ Automated Microbiology System | Becton Dickinson & Co | LON | Class II | |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | |
| K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical | DQK | Class II | |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer GmbH | JWH | Class II | |
| K243587 | PureLift GLOW | Xtreem Pulse | NFO | Class II | |
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics | QNI | Class II | |
| K243331 | LVivo Seamless | Dia Imaging Analysis, Ltd. | QIH | Class II | |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic, S.A. de C.V. | FRO | Unclassified | |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | QAI | Class II | |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International SA | LZO | Class II | |
| K250304 | TITANEX Screw Systems | Vilex LLC | HWC | Class II | |
| K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | OLO | Class II | |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | Siemens Healthcare Diagnostics Inc. | CGR | Class II | |
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty Ltd | QSZ | Unclassified | |
| K241770 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | QDQ | Class II | |
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co. Ltd | GBM | Class II | |
| K243933 | Ceevra Reveal 3+ | Ceevra, Inc. | QIH | Class II | |
| K243809 | Biolox® Delta Revision heads | Limacorporate S.p.A. | LZO | Class II | |
| K243461 | Calibrate Interbody Systems | Alphatec Spine, Inc. | |||
| K241679 | Disposable Cytology Brush (AF series) | Alton Shanghai Medical Instruments Co Ltd | KTI | Class II | |
| K232383 | iPhysio® System | Euroteknika | NHA | Class II | |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | JAQ | Class II | |
| K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. | KPS | Class II | |
| K243611 | Jlk-Sdh | JLK, Inc. | QAS | Class II | |
| K243380 | Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) | Olympus Medical Systems Corp. | EOB | Class II | |
| K243235 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) | Beijing Nubway S&T Co.,Ltd. | GEX | Class II | |
| K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | Qiagen | PCH | Class II | |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | MOS | Class II | |
| K244039 | MedalOne Total Knee System | Suzhou MicroPort Orthorecon Co., Ltd. | JWH | Class II | |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K243730 | Xpert C. difficile/Epi | Cepheid | OZN | Class II | |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. | NAY | Class II | |
| K243565 | DYNAMIS™ SI Screw System | Promethean Restorative Inc. | OUR | Class II | |
| K243436 | Seclusion Catheter | Basis Medical | DQY | Class II | |
| K243359 | MagDI System (MAG-02, DS-01) | GT Metabolic Solutions, Inc. | SAH | Class II | |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | DQA | Class II | |
| K242798 | Airmod | Heroic Faith International Ltd. | BZQ | Class II | |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co.,Ltd | CAW | Class II | |
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Inc | POL | Class II |