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 |
|---|---|---|---|---|---|
| K091673 | Ge Lightspeed Act Fp16 | GE Healthcare | JAK | Class II | |
| K091546 | Noras or Head Coil 3T, Models Si7200/si72100/si7220/si7230 | NORAS MRI products GmbH | MOS | Class II | |
| K091291 | Xia 3 Spinal System, Uniplanner/reduction Screws & Vitallium Rod | Howmedica Osteonics Corp | NKB | Class II | |
| K091035 | Full Breath Sleep Appliance Lower (Fbsl) | Bryan Keropian Dds | LQZ | Class II | |
| K091026 | Tds Abutment for Nobel Biocare Replace | Pou YU Biotechnology Co., Ltd. | NHA | Class II | |
| K090564 | Truly Infrared Ear Thermometer, Model Tet-350, Tet-360, Tet-370 | Truly Instrument Limited | FLL | Class II | |
| K090109 | Blood Gas, Electrolyte and Metabolite Test Card | Epocal Inc | CGA | Class II | |
| K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corporation | MBI | Class II | |
| K091427 | Vinyl Powdered Examination Glove | Shun da (Xinghua) Co., Ltd. | LYZ | Class I | |
| K091209 | Portalvision Advanced Imaging | Varian Medical Systems, Inc. | IYE | Class II | |
| K091056 | Rhythmlink Disposable Monopolar EMG Needle, Model Tfdn26032252r | Rhythmlink International, LLC | IKT | Class II | |
| K091055 | Rhythmlink Disposable Concentric EMG Needle, Model D039032252r | Rhythmlink International, LLC | IKT | Class II | |
| K090668 | Vision Tools | Millensys | LLZ | Class II | |
| K090462 | Brilliance Dual Energy Option | Philips North America LLC | JAK | Class II | |
| K090417 | Axxent Flexishield Mini | Xoft, Inc. | IXI | Class II | |
| K090404 | Fore V10 Blood Glucose Monitoring System, Model Td-4244, Forea V12 Blodo Glucose Monitoring System, Model Td-4247 | Taidoc Technology Corporation | NBW | Class II | |
| K090393 | Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139,72202141, 72202143, 72202144 | ArthroCare Corporation | GEI | Class II | |
| K090375 | Orthopilot Next Generation-Uka Software, Model Fs210 | Aesculap Implant System, Inc. | OLO | Class II | |
| K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd | GXY | Class II | |
| K083895 | Codman Isocool Bipolar Forceps | Cerenovus, Inc. | GEI | Class II | |
| K083690 | Femvue(tm) Catheter System | Femasys Inc. | LKF | Class II | |
| K083520 | Intelepacs, Model Version 3.X.x | Intelerad Medical Systems Incorporated | LLZ | Class II | |
| K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | MTJ | Unclassified | |
| K091593 | Angio Jet Ultra Dvx and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | QEZ | Class II | |
| K091032 | Cerner Provision Workstation (Version 2.5) | Cerner Corporation | LLZ | Class II | |
| K090891 | Microplex Coil System-Cosmos | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170cr | Linvatec Corporation | MAI | Class II | |
| K090431 | Dexis Software | Dexis, LLC | LLZ | Class II | |
| K083601 | Lambda Light Chains | Sentinel CH SpA | DEH | Class II | |
| K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 | LED Intellectual Properties LLC | ILY | Class II | |
| K080469 | Vidas Ca 15-3 Assay | bioMerieux, Inc. | LTK | Class II | |
| K091680 | Digital Ultrasonic Diagnostic Imaging System | Edan Instruments, Inc. | ITX | Class II | |
| K091551 | Vari-Lase Platinum Bright Tip Laser Fiber | Vascular Solutions LLC | GEX | Class II | |
| K091509 | Jetstream G2 Nxt System, Model Pv20300 | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7mm,6x9mm, Micrus Summit Occlusion Balloon Catheter 4X10mm,4x15, Model Brs 00 | Micrus Endovascular Corporation | MJN | Class II | |
| K091038 | As 1000 Ultrasound Wound Therapy System | Arobella Medical, LLC | NRB | Class II | |
| K090987 | Vascutek Branched Gelweave | Vascutek, Ltd. | DSY | Class II | |
| K090962 | Cyber Surgical Laser Family Including: Cyber Tm, Cyber Green, Cyber Green Tm | Quanta System Inc. | GEX | Class II | |
| K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | QYX | Class II | |
| K090621 | Flowcardia Flowmater Injector, Model Inj 100 | Flowcardia, Inc. | DXT | Class II | |
| K090099 | Dss Stabilization System | Paradigm Spine GmbH | NKB | Class II | |
| K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model Kp-7500, Fully Fuzzy Auto Digital Upper Arm Blood Pressu | K-Jump Health Co., Ltd. | DXN | Class II | |
| K083644 | Mako Surgical Tactile Guidance System-Hip | Mako Surgical Corp. | OLO | Class II | |
| K082843 | Modificaton to: Dentis Dental Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K082340 | Roche Elecsys Folate III, Roche Elecsys Rbc Folate Hemolysing Reagent, Roche Elecsys Folate III Calset, Roche Elecsys | Roche Diagnostics GmbH | CGN | Class II | |
| K091669 | Open Magnetic Resonance Imaging System, Model Mpf3000-III | Xioao Mdt Technology Co, Ltd. | LNH | Class II | |
| K091602 | Mucheck V8 | Oncology Data Systems, Inc. | IYE | Class II | |
| K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | MCUBE TECHNOLOGY Co.,Ltd. | IYO | Class II | |
| K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K091478 | Trevair Chair | Patmont Motor Werks, Inc. | IOR | Class I |