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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K060717 | Nurse Assistant 1.7 o.r. Control System | Conmed Integrated Systems (Cmis) | GCJ | Class II | |
| K060660 | Ew200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter | Edwards Lifesciences LLC | DXG | Class II | |
| K060376 | Simpler Ha Threaded, St 5002-8, Sit 5002-8, St 5011-St5014, St 5021-24 | Simpler Implant, Inc. | DZE | Class II | |
| K060016 | Thromcat Thrombectomy Catheter System | DSM Biomedical, Inc. | MCW | Class II | |
| K053415 | Lesionpoint RF Cannula | Boston Scientific Neuromodulation Corporation | GXI | Class II | |
| K053263 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model Cn1003 | Cardionet, LLC | DSI | Class II | |
| K050674 | Physioglove Es | Commwell, Ltd. | DPS | Class II | |
| K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/hpt Performance Verifier I, II, and III | Ortho-Clinical Diagnostics, Inc. | JIX | Class II | |
| K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | DWJ | Class II | |
| K060807 | Scoutpro 7F Coronary Sinus Lead Delivery System | BIOTRONIK AG | DQY | Class II | |
| K060733 | Synthalon Pi Powder-Free Synthetic Polyisoprene/polychloroprene Examination Gloves Mdl 1362-10 to 1362-44 | Barriermed, Inc. | LZA | Class I | |
| K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | KLE | Class II | |
| K060640 | Digirex Digital Dental Radiography System | Dentamerica | EHD | Class II | |
| K060462 | Neomarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone Sp2) | Lab Vision Corp. | MXZ | Class II | |
| K060195 | Gambro Polyflux Hd-C4 Capillary Dialyzer/filter for Single Use | Gambro Renal Products | KDI | Class II | |
| K060168 | Vitrification Freeze Kit, Vitrification Thaw Kit | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K060140 | Crp-Advance Multi Calibrator Set, Model Se-250 | Sekisui Diagnostics P.E.I. Inc. | JIT | Class II | |
| K060111 | Iva (Mxa II Software Option) | Hologic, Inc. | KGI | Class II | |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, Thc | Tianjin New Bay Bioresearch Co., Ltd. | DJG | Class II | |
| K060954 | Modification to Ensite System, Model Ee3000 | St. Jude Medical, Inc.-Endocardial Solutions | DQK | Class II | |
| K060835 | Hl888sf | Health & Life Corporation | DXN | Class II | |
| K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088 | Abbott Medical | FRN | Class II | |
| K060774 | Folate on the Access Immunoassay Systems, Model A14208 | Siemens Healthcare Diagnostics Inc. | CGN | Class II | |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips | Abbott Medical | JIN | Class I | |
| K060679 | Surtrak Implantation Kit | North American Scientific, Inc. | KXK | Class II | |
| K060646 | Blue Luxcer Curing Light, Models M-830, M-835 and M-855 | Monitex Industrial Co., Ltd. | EBZ | Class II | |
| K060621 | Susceptibility Test Plate for Ertapenem 0.002-16Ug/ml for Gram Negative. Susceptibility Test Plate for Ertapenem 0.015- | Tds Holdings, Inc. | JWY | Class II | |
| K060613 | Variax Locking Plate System | Howmedica Osteonics Corp | KTT | Class II | |
| K060573 | Burbank Tenaculum | Vascular Control Systems, Inc. | HDC | Class II | |
| K060555 | Spraygenix Cryo Ablation System | Crymed Technologies, Inc. | GEH | Class II | |
| K060545 | Unity Humeral Plate | TORNIER Inc. | KTT | Class II | |
| K060466 | Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device | Acon Laboratories, Inc. | DJG | Class II | |
| K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F | Barrx Medical, Incorporated | GEI | Class II | |
| K060166 | Ohmega | Medical Measurement Systems B.V. | FFX | Class II | |
| K053386 | Xltek Emu40 EEG Headbox, Model Pk1072 | Excel Tech., Ltd. | GWQ | Class II | |
| K060843 | Modification to Health Buddy Appliance | Health Hero Network, Inc. | DQA | Class II | |
| K060625 | Nexus Detachable Coil System, Morpheus 3D Csr | Medtronic, Inc. | HCG | Class II | |
| K060579 | Comfort/io Iontophoresis Electrodes | Pepin Mfg., Inc. | EGJ | Class II | |
| K050094 | Lady Comp USA | Lady Comp USA | LHD | Unclassified | |
| K060962 | Endogator Endoscopy Irrigation Pump, Model Egp-100 | Byrne Medical, Inc. | OCX | Class II | |
| K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20mhz Models 37410/456221/C1020 | Boston Scientific Corporation | ITX | Class II | |
| K060941 | Caas Mrv Version 3.0 | PIE Medical Imaging B.V. | LLZ | Class II | |
| K060912 | Modification to: Hi-Art System | Accuray Incorporated | IYE | Class II | |
| K060879 | Model Ec9-4 Transducer | Siemens Medical Solutions USA, Inc. | ITX | Class II | |
| K060834 | Probeat with Mgcs | Hitachi, Ltd. | LHN | Class II | |
| K060828 | Modification to Endotine Ribbon | Coapt Systems, Inc. | GAM | Class II | |
| K060757 | Inquiry Optima Plus Steerable Electrophysiology Catheter | Irvine Biomedical. Inc. | DRF | Class II | |
| K060750 | Stryker Injectable Cement | Stryker Cmf | NEA | Class II | |
| K060731 | Evolve Modular Radial Head | Wrightmedicaltechnologyinc | KWI | Class II | |
| K060712 | Vitelcare C-Turtle Patient Monitoring System | Visual Telecommunications Network, Inc. | MWI | Class II |