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 |
|---|---|---|---|---|---|
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc | OLO | Class II | |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | KNS | Class II | |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | IYE | Class II | |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics Inc. | JZO | Class II | |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | NFO | Class II | |
| K250203 | SureAx-Guide™ | Sureax Medical, Corporation | DQX | Class II | |
| K250197 | Estremo Fibular Nail | Citieffe Inc. | HSB | Class II | |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems Ltd. | NHA | Class II | |
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group Ltd. | SGG | Class II | |
| K250145 | Biopsy Port Adapter | Endosound Inc | ODC | Class II | |
| DEN240076 | Modius Lean | Neurovalens | SFW | Class I | |
| K253114 | TargetCool™ (RM-DT02W) | Recensmedical Inc. | GEH | Class II | |
| K253024 | ProZip Knotless Implant | Riverpoint Medical, LLC | GAT | Class II | |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | GEH | Class II | |
| K252631 | Profoject™ Disposable Needle | CMT Health Pte. Ltd. | FMI | Class II | |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra Inc. | QEW | Class II | |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab, Inc. | LLZ | Class II | |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corp. | FBK | Class II | |
| K252223 | Alpha Endo Handpiece (Alpha Endo) | Shenzhen Superline Technology Co.,Ltd | EKX | Class I | |
| K252153 | FFX Facet Fixation System | SC Medica | MRW | Unclassified | |
| K252093 | Light Therapy Mask (1019055) | Merchsource LLC | OHS | Class II | |
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis, Inc | QHH | Class II | |
| K251994 | Arthrex Synergy Vision Imaging System | Arthrex GmbH | GCJ | Class II | |
| K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd. (Wuxi) | HHK | Class II | |
| K251497 | Elos Accurate Hybrid Base | Elos MedTech Pinol a/S | NHA | Class II | |
| K250852 | Coolfase | Asterasys Co., Ltd. | GEI | Class II | |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | NVK | Class II | |
| K243727 | Re:Balans | Mode Sensors AS | DSB | Class II | |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | KGN | Unclassified | |
| K253348 | TargetCool-e | Recensmedical Inc. | GEH | Class II | |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | ConMed Corporation | MAI | Class II | |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors LLC | NHA | Class II | |
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | QZZ | Class II | |
| K252367 | InbellaMulti System | Inbella Medical Inc. | GEI | Class II | |
| K252199 | AGFA HealthCare Enterprise Imaging | AGFA Healthcare Corp. | LLZ | Class II | |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab Inc | HRX | Class II | |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K251294 | Bonafix Implant Abutments | Zentek Medical LLC | NHA | Class II | |
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) | ZOLL Circulation, Inc. | NZE | Class II | |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) | Feeltech Co.,Ltd. | NEW | Class II | |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | EBZ | Class II | |
| K253331 | PressON Spinal Fixation System | Nexus Spine, L.L.C. | NKB | Class II | |
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio Control, Inc. | MPD | Class II | |
| K253010 | Mini Superhawk Suture Anchor System | Responsive Arthroscopy | MBI | Class II | |
| K252637 | Community Containers (Flap and Daisy) | Keter Canada Inc. | MMK | Class II | |
| K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) | Shenzhen Qiaochengli Technology Co., Ltd | OHT | Class II | |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | MMK | Class II | |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | LHI | Class II |