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 |
|---|---|---|---|---|---|
| K081041 | Gps, G Surgical Pedicle System | G Surgical Co., Ltd. | MNH | Class II | |
| K080959 | Dornier Medilas D 30 Laser, Medilas D 1064 | Dornier Medtech America, Inc. | GEX | Class II | |
| K080955 | Zen Program (Mind 440 Hearing Aid) | Widex Hearing Aid Co., Inc. | KLW | Class II | |
| K080828 | Mountaineer Oct Spinal System | DePuy Spine, Inc. | MNH | Class II | |
| K080798 | Intel Health Guide, Model: Phs6000 | Intel Corp. | DRG | Class II | |
| K080679 | Modification to Cortrak Enteral Access Device, Model 20-0900 | Viasys Medsystems | KNT | Class II | |
| K080617 | Power Drive Art1 2304 with Motor Handles, Tools and Accessories | Richard Wolf Medical Instruments Corp. | HRX | Class II | |
| K080604 | Pressure Injfectable Picc | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | Class II | |
| K080497 | Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell Ag) | Derma Sciences Canada, Inc. | FRO | Unclassified | |
| K080283 | Ideal Life Gluco-Manager Gmm 0001 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K073644 | Endogastric Solutions Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | OCW | Class II | |
| K073631 | Orqis Extracorporeal Blood Pumping System, Model Bps-100 | Orqis Medical Corporation | KFM | Class II | |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265 | Siemens Healthcare Diagnostics Inc. | MQM | Class I | |
| K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 | Alma Lasers Ltd. | GEX | Class II | |
| K071984 | Modification to Cma Cerebral Tissue Monitoring System | Cma Microdialysis AB | GWM | Class II | |
| K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | QEY | Class II | |
| K081362 | Platelia Lyme Igm | Bio-Rad | LSR | Class II | |
| K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K080734 | Flowscreen, Flowscreen/corscreen, Flowscreen CT | Viasys Healthcare GmbH | BTY | Class II | |
| K073702 | Phoneris Inner Cannulae with Phoneris Aero-Flex Ventilator Circuit Connector | Lazarus Medical, Inc. | BTO | Class II | |
| K073223 | S-Test C02 | Alfa Wassermann Diagnostic Technologies, Inc. | KHS | Class II | |
| K072962 | Cabs'air | Cousin Biotech SAS | FTL | Class II | |
| K072142 | S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast | Alfa Wassermann Diagnostic Technologies, Inc. | CKF | Class II | |
| K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | ConMed Corporation | GEI | Class II | |
| K081612 | Aesculight Family of Flexible Fibers, Handpieces and Tips for CO2 Surgical Lasers | Aesculight, LLC | GEX | Class II | |
| K081533 | Sentinel Plasmaproteins Cal 3X | Sentinel CH SpA | JIX | Class II | |
| K081483 | Xtag Respiratory Viral Panel | Luminex Molecular Diagnostics Inc | OCC | Class II | |
| K081395 | Solitaire Peek-Optima Anterior Spinal System | Highridge Medical, LLC | OVD | Class II | |
| K080962 | Lite Wand II | Thompson Surgical Instruments, Inc. | FST | Class II | |
| K080812 | Hemoccult Ict | Siemens Healthcare Diagnostics Inc. | KHE | Class II | |
| K080600 | Ultimed Ulticare Safety Syringe | Ultimed, Inc. | MEG | Class II | |
| K080381 | Quest Diagnostics Methamphetamine Micro-Plate Eia | Quest Diagnostics, Inc. | LAF | Class II | |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | Siemens Healthcare Diagnostics Inc. | DHX | Class II | |
| K081661 | Hd15 Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K081648 | Digital Radiography Cxdi-60G | Canon, Inc. | MQB | Class II | |
| K081471 | Ecard and Ccard | iRhythm Technologies, Inc. | DXH | Class II | |
| K081160 | Avita Radar Thermo Ir Thermometer, Nt1 Series | Avita Corporation | FLL | Class II | |
| K080886 | Iplan Rt Image | Brainlab, Inc. | LHN | Class II | |
| K080879 | Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm | Bioretec Ltd. | HTY | Class II | |
| K080816 | Visual Footcare Technologies Tempstat | Visual Footcare Technologies, LLC | OIZ | Class I | |
| K080639 | Symphony Glucose Management System | Animas Corp. | LZG | Class II | |
| K080223 | Zura Tee System | IMACOR, Inc | IYO | Class II | |
| K080197 | Plasmajet Neutral Plasma Surgery System | Plasma Surgical Inc. | GEI | Class II | |
| K080181 | Modification to Galileo Gold | Hamilton Medical AG | CBK | Class II | |
| K073556 | Medxpert P.e.s. (Pectus Exacvatum System), Medxpert Stratos | MedXpert GmbH | HRS | Class II | |
| K072861 | Ceemax Slit Lamp (Halogen Lamp Series/solid State Illumination Series) | Acheve Technology, Inc. | HJO | Class II | |
| K072356 | S-Test Ca | Alfa Wassermann Diagnostic Technologies, Inc. | CJY | Class II | |
| K072326 | Ostapek Vbr System | Co-Ligne AG | MQP | Class II | |
| K072141 | S40 Clinical Analyzer, S Test Ip, S Test Ua | Alfa Wassermann Diagnostic Technologies, Inc. | CEO | Class I | |
| K072140 | S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu | Alfa Wassermann Diagnostic Technologies, Inc. | CFR | Class II |