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 |
|---|---|---|---|---|---|
| K081691 | Inomax Ds (Delivery System) | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K081652 | Claros Nano Dental Laser System | Elexxion AG | GEX | Class II | |
| K081606 | Baha Intenso | Cochlear Americas | LXB | Class II | |
| K081559 | Genesis | Medisiss | GEI | Class II | |
| K081550 | Bonart Ultrasonic Scaler, Moedls Art-P3ii Pro and Art-Mii Pro | Bonart Co. Ltd. | ELC | Class II | |
| K081488 | Powder Free Latex Examination Gloves, Non-Sterile | P.T. Maja Agung Latexindo | LYY | Class I | |
| K081464 | Sterile, Powder-Free, Latex Exam Gloves, Models 2D7018pf Series, 2D7028pf Series | Cardinalhealth | LYY | Class I | |
| K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, Ch-Xxxx | Abbott Medical | FPA | Class II | |
| K080873 | Opacity + Bone Cement | Teknimed SAS | NDN | Class II | |
| K080448 | Centurion Protective Restraint, Scr Series | Centurion Medical Products, LP | FMQ | Class I | |
| K080405 | Sygnal Dbm | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | MBP | Class II | |
| K073197 | Silver Antimicrobial Wound Gel | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K071023 | Reach Rcs Circular Stapler, Model Rcs21c, Rcs25c, Rcs28c, Rcs31c, Rcs34c | Reach Surgical, Inc. | GDW | Class II | |
| K082304 | Roll-X Guidewire | Abbott Medical | DQX | Class II | |
| K082127 | Strata Nsc Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635 | Medtronic Neurosurgery | JXG | Class II | |
| K082112 | T2 Xvbr Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K081762 | Curbell Patient Monitoring Cables | Curbell Electronics, Inc. | DSA | Class II | |
| K081508 | Hg Oxygen Concentrator, Models Hg5-W & Hg5-Wn | Shenyang Canta Medical Tech. Co., Ltd | CAW | Class II | |
| K081275 | Boston Scientific Surgical Mesh | Boston Scientific Corporation | PAH | Class II | |
| K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | MJN | Class II | |
| K080554 | Inarex, Model 2D-Lx | Inarex Corporation | JFB | Class II | |
| K073158 | Sculpture 2.94 Er:yag System | Hoya Conbio, Inc. | GEX | Class II | |
| K082173 | Q-Stress and Heartstride, Models Qstress/q40 and H4/h4s | ZOLL Medical Corporation | DPS | Class II | |
| K081903 | Xios Plus Wall-Module | Sirona Dental Systems GmbH | MUH | Class II | |
| K081726 | Tysonbio Link Health Management System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K081708 | Taxi Endoscopic Guidewire | Lake Region Mfg., Inc. | OCY | Class II | |
| K081546 | Small Bone Locking Plating System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K081516 | Medsource CPR Mask with & without Oxygen Port | Medsource International, LLC | CBP | Class II | |
| K081511 | 2.0 Pk Suture Anchor T, 2.0 Pk Suture Anchor S | Smith & Nephew, Inc. | MBI | Class II | |
| K081215 | Volumina | Kjaya Medical, LLC | LLZ | Class II | |
| K081180 | Skinsense Polyisoprene Underglove | Molnlycke Health Care, US LLC | KGO | Class I | |
| K073633 | Stryker Essx Microdebrider System | Stryker Ireland Ltd., Instruments Division | ERL | Class II | |
| DEN080007 | Allomap Molecular Expression Testing | Xdx | OJQ | Class II | |
| K082318 | Centricity Pacs Iw | GE Healthcare Dynamic Imaging Solutions | LLZ | Class II | |
| K082143 | Micro Guide Catheter Xp | Cordis US Corp. | PDU | Class II | |
| K082098 | Sonosite Maxx Series Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K082005 | Modification to Hi-Art Treatment System | Accuray Incorporated | MUJ | Class II | |
| K081558 | Pioneer Surgical Technology Nanoss Bvf-E, Models 5, 10, 20Cc | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K081468 | Devilbiss Portable Oxygen Concentrator, 306 Series | Sunrise Medical, Inc. | CAW | Class II | |
| K081247 | Tm-400 | Ito Co., Ltd. | ITH | Class II | |
| K081237 | Craftmaster Contour Equipment, Inc., Vista Model V-20, Satellite Mobile Unit Model St-98 and Satellite Unit | Craftmaster Contour Equipment, Inc. | EIA | Class I | |
| K080761 | Bonart's Arteotomy Omi and Opi Ultrasonic Surgery System & Accessories | Bonart Co. Ltd. | DZI | Class II | |
| K080040 | Ortho All-Flex Diaphragm | Johnson & Johnson Produtos Profissionais Ltda. | HDW | Class II | |
| K071961 | Mesacup Models Bp180 and Bp230 Elisa Kits | Mbl International Corporation | OEG | Class II | |
| K082294 | Westar Series Dental Units | Westar Medical Products, Inc. | EIA | Class I | |
| K082197 | Rhytec, Inc., Portrait Psr | Rhytec Incorporated | GEI | Class II | |
| K082067 | Msc Lipid Control | Maine Standards Co. | JJY | Class I | |
| K082064 | Radvision Et Diagnostic X-Ray System | Almana Medical Imaging | KPR | Class II | |
| K082030 | Dimension Vista Csae Calibrator, Model Kc440 | Siemens Healthcare Diagnostics Inc. | DLJ | Class II | |
| K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face Shields | Hsiner Co., Ltd. | CAF | Class II |