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 |
|---|---|---|---|---|---|
| K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | |
| K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula | Edwards Lifesciences LLC | DWF | Class II | |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CGA | Class II | |
| K200183 | Cs 9600 | Trophy | OAS | Class II | |
| K200075 | 3DMetal Diaphyseal Femoral Cones | Medacta International SA | JWH | Class II | |
| K200069 | Disposable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | DQA | Class II | |
| K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | KDI | Class II | |
| K193418 | SeaSpine Skipjack System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K193325 | Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches | Prosys International Ltd | KNT | Class II | |
| K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | Penumbra Inc. | QEW | Class II | |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | QKM | Class II | |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K192925 | 32Hl512d | LG Electronics.Inc | PGY | Class II | |
| K192888 | EzOrtho | Ewoosoft Co., Ltd | LLZ | Class II | |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience Inc | LYR | Class I | |
| K192720 | GIA Stapler with Tri-Staple Technology | Medtronic, Inc. | GDW | Class II | |
| K192483 | MeDioStar | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | O&M Haylard, Inc. | LZA | Class I | |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | GXR | Class II | |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | Molnlycke Health Care, US LLC | KGO | Class I | |
| K200341 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K200263 | Health Line CT Midline Catheter | Health Line International Corporation | FOZ | Class II | |
| K193612 | AMT Suture Delivery System | Applied Medical Technology Inc | KGC | Class II | |
| K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml | Thermo Fisher Scientific Oy | JWY | Class II | |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | JDQ | Class II | |
| K193448 | BioNourish Lubricant | Good Clean Love, Inc. | NUC | Class II | |
| K193367 | elysion-pro | High Technology Products, SLU | GEX | Class II | |
| K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | IYN | Class II | |
| K192338 | NEOLab Clear Aligners | New England Ortho Lab, Inc. | NXC | Class II | |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | MRZ | Class II | |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | DIO | Class II | |
| K190978 | RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. | IYE | Class II | |
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular Inc. | DKZ | Class II | |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | OQG | Class II | |
| K193447 | Vista Dyes | Inter-Med/Vista Dental Products | LFC | Class II | |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PBF | Class II | |
| K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K192810 | Apollo Suture Anchor System | Valeris Medical | MBI | Class II | |
| K192484 | Fixone Biocomposite Anchor | Aju Medical Co., Ltd. | MAI | Class II | |
| K190129 | AC5 Topical Gel | ARCH Therapeutics | FRO | Unclassified | |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers for Disease Control and Prevention | OZE | Class II | |
| K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | PGW | Class II | |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical, Ltd. | MRN | Class II | |
| K193446 | Bare: 808 | Luvo Medical Technologies, Inc. | GEX | Class II | |
| K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder Free | JR Engineering and Medical Technologies (M) Sdn Bhd | KGO | Class I | |
| K200258 | Edwards eSheath Introducer Set | Edwards Lifesciences LLC | DYB | Class II | |
| K200049 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K200048 | MectaLIF Anterior Simple | Medacta International SA | MAX | Class II |