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 |
|---|---|---|---|---|---|
| K193306 | PROView | GE Medical Systems SCS | LLZ | Class II | |
| K203149 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International SA | NKG | Class II | |
| K202762 | Circular Fixation with Balanced Cable Transport | Smith & Nephew, Inc. | KTT | Class II | |
| K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | Shangdong Huamei Technology Co., Ltd. | GEX | Class II | |
| K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | IPF | Class II | |
| K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | |
| K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | DZE | Class II | |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K201918 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K201060 | Cordiana Dx16 | Cordiana Medical Informatics AG | DQK | Class II | |
| K200706 | Sientra OPUS Silicone Gel Breast Implant Sizer | Sientra, Inc. | MRD | Unclassified | |
| K200461 | Freeprint denture | Detax GmbH & Co. KG | EBI | Class II | |
| K193193 | Telio CAD Abutment Solutions- extra systems | Ivoclar Vivadent, Inc. | NHA | Class II | |
| K200401 | Apogee | Incoba Ltd D/B/A Dynaris | NFB | Class II | |
| K203040 | TSolution One Total Knee Application | Think Surgical Inc. | OLO | Class II | |
| K203011 | Monster Screw System | Paragon 28 | HWC | Class II | |
| K202966 | SIGNA Architect | GE Healthcare (GE Medical Systems, LLC) | LNH | Class II | |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic CryoCath LP | DRA | Class II | |
| K202373 | APEX 3D Total Ankle Replacement System | Paragon 28 | HSN | Class II | |
| K202355 | Stryker Omega PEEK Knotless Anchor System | Stryker Corp. | MBI | Class II | |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K202178 | VersaLoop Anchor System | T.A.G. Medical Products Corporation Ltd | MBI | Class II | |
| K202132 | Venue | GE Healthcare | IYN | Class II | |
| K201937 | Ceramir Restore QuikCap | Doxa Dental AB | EMA | Class II | |
| K201881 | CoroFlow Cardiovascular System | Coroventis Research AB | DQK | Class II | |
| K201666 | Single Use Manometer | Flexicare Medical Ltd. | CAP | Class II | |
| K200820 | SpeediCath Compact Set | MEDLINE INDUSTRIES, LP - Northfield | GBM | Class II | |
| K200239 | Astroglide Organix Gel | Biofilm, Inc. | NUC | Class II | |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | |
| K192612 | Kerecis Gingiva Graft | Kerecis Limited | NPL | Class II | |
| DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences LLC | QMS | Class II | |
| K203173 | ExacTrac Dynamic | Brainlab, Inc. | IYE | Class II | |
| K203085 | NOVA Patient Warming System | Encompass Group LLC | DWJ | Class II | |
| K203082 | Insight Infrared Video Goggles | Vestibular First | GWN | Class II | |
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | |
| K202074 | Apache Ultrasound System (Model C62) | Compal Electronics, Inc | IYN | Class II | |
| K201985 | KardiaAI | AliveCor | DQK | Class II | |
| K201568 | Calvary Spine Pedicle Screw System | Calvary Spine, LLC | NKB | Class II | |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd | MMK | Class II | |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | FRG | Class II | |
| K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | FRG | Class II | |
| K200334 | AN1036 Dosimeter | Andersen Sterilizers, Inc. | JOJ | Class II | |
| K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | BTT | Class II | |
| K193385 | TP Orthodontics Clear Aligner System | TP Orthodontics, Inc. | NXC | Class II | |
| K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | JAK | Class II | |
| K192980 | EOGas 4 Endo-SteriTest | Andersen Sterilizers, Inc. | FRC | Class II | |
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | FLF | Class II | |
| K191433 | AGILON® XO Shoulder Replacement System | implantcast GmbH | HSD | Class II | |
| K203043 | Route 92 Medical 070 Access System | Route 92 Medical, Head Quarters | QJP | Class II | |
| K203106 | Nio Fusion 12MP (MDNC-12130) | Barco N.V. | PGY | Class II |