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 |
|---|---|---|---|---|---|
| K200916 | Patient Administration Set | Cyclomedica Australia Pty Ltd | IYT | Class II | |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | OOE | Class II | |
| K193424 | Resolution 360™ ULTRA Clip | Boston Scientific Corporation | PKL | Class II | |
| K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | Penumbra Inc. | NRY | Class II | |
| K201831 | CONFIDENCE Spinal Cement System | DePuy Spine, Inc. | NDN | Class II | |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PPT | Class II | |
| K193589 | TrueTear Intranasal Tear Neurostimulator | Allergan | QBR | Class II | |
| K201405 | LabPro Data Management System | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | |
| K202224 | SpaceOAR System | Boston Scientific Corporation | OVB | Class II | |
| K202108 | External Counterpulsation System, Soulaire | Vamed Medical Instrument Co.,Ltd | DRN | Class II | |
| K202099 | AOS Galileo™ Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K201476 | DreaMed Advisor Pro | Dreamed Diabetes Ltd | QCC | Class II | |
| K201199 | Jada System | Alydia Health | OQY | Class II | |
| K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | KNW | Class II | |
| K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | Spinal Stability, LLC | MAX | Class II | |
| K200926 | OrthoGold 100 | Tissue Regeneration Technologies | PZL | Class II | |
| K200859 | Infinity M300 | Draeger Medical Systems, Inc. | MHX | Class II | |
| K200369 | OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH | FGB | Class II | |
| K193005 | DIMI RRT System | Dialco Medical, Inc. | KDI | Class II | |
| K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | QSY | Unclassified | |
| K191938 | FitRelief TENS&EMS Wireless Device | Heat in a Click LLC | NGX | Class II | |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | OAT | Class II | |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | QAX | Class II | |
| K201981 | Magicore System | Innobiosurg Co., Ltd. | DZE | Class II | |
| K201830 | ANSER Clavicle Pin | Baat Medical Products B.V. | HSB | Class II | |
| K201807 | Ancoris | Miegmbh | KPS | Class II | |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | DXJ | Class II | |
| K201115 | Next Generation Balloon Dilation System | Acclarent Inc | LRC | Class I | |
| K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | LLZ | Class II | |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | Procter & Gamble Co. | JEQ | Class I | |
| K192953 | APTOS Threads – Polypropylene Surgical Sutures | Aptos LLC | GAW | Class II | |
| K192062 | Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | DZE | Class II | |
| K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | OCT | Class II | |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | GZT | Class II | |
| K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | KWQ | Class II | |
| K201856 | Provicol QM Aesthetic | Voco GmbH | EMA | Class II | |
| K201805 | VersaOne Reusable Positioning Trocar System | Medtronic, Inc. | GCJ | Class II | |
| K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | FXX | Class II | |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | LRC | Class I | |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | MAX | Class II | |
| K201141 | Firmm | Nous Imaging, Inc. | LNH | Class II | |
| K201020 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K200923 | Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. | FXX | Class II | |
| K200796 | Emprint Ablation System with Thermosphere Technology | Medtronic, Inc. | NEY | Class II | |
| K200714 | Aview | Coreline Soft Co., Ltd. | LLZ | Class II | |
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med SpA | FOZ | Class II | |
| K193653 | Hydrophilic Coating Guide Wire | Suzhou Hengrui Disheng Medical Co., Ltd. | DQX | Class II | |
| K193177 | Cer-S | Cardiocalm SRL | MLO | Class II | |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | CTL Medical Corporation | MAX | Class II |