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 |
|---|---|---|---|---|---|
| K070998 | Inion Biorestore | Inion Oy | MQV | Class II | |
| K070773 | Axya, Model 3000 Axyzloop Titanium Bone Anchor | TORNIER Inc. | MBI | Class II | |
| K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test | Luminex Corporation | NSU | Class II | |
| K072667 | Sharps Away Disposable Container | Solutions, Inc. | MMK | Class II | |
| K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | IZI | Class II | |
| K072323 | Masterscreen & Oxycon Cpx | Viasys Healthcare GmbH | BZC | Class II | |
| K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K072113 | Integra Flowable Wound Matrix, Model Fwd301 | Integra LifeSciences Corporation | KGN | Unclassified | |
| K071808 | Mirage Micro | ResMed Corp | BZD | Class II | |
| K071638 | Biohorizons Tapered Internal Implant System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K071491 | Arrow International, Inc., Surgical Drapes | Arrow Intl., Inc. | KKX | Class II | |
| K071484 | Periacryl 90,80,70,60, Model9010, 8020, 7030, 6040 | Glustitch, Inc. | EMA | Class II | |
| K071128 | Scanscope Xt System | Leica Biosystems Imaging, Inc. | NOT | Class II | |
| K071097 | Navigator Applications Suite | GE Healthcare Finland Oy | BSZ | Class II | |
| K070870 | Skin Care Light | Transverse Industries Co. | GEX | Class II | |
| K071881 | Triathlon Pkr System | Howmedica Osteonics Corp | HRY | Class II | |
| K071621 | Reliant Technologies C300 Chiller System and Accessories | Reliant Technologies, Inc. | GEX | Class II | |
| K071466 | Dca Vantage, Model 5075 | Siemens Healthcare Diagnostics Inc. | LCP | Class II | |
| K071405 | Probe Holder System | Intuitive Surgical, Inc. | LKF | Class II | |
| K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K063705 | Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, Tdm Calibration Set B, Nortrol and Abtrol | Thermo Electron Oy | NDW | Class II | |
| K072737 | Cscs-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent Xl | Alma Lasers Ltd. | GEI | Class II | |
| K072674 | Kii Trocar System | Applied Medical Resources Corp | GCJ | Class II | |
| K072572 | Primaconnex Rd and Wd Esthetic Contour Zi Abutments | Lifecore Biomedical LLC | NHA | Class II | |
| K072568 | Modification to Oasys System | Howmedica Osteonics Corp | KWP | Class II | |
| K072559 | Suction Coagulator | Megadyne Medical Products, Inc | GEI | Class II | |
| K072546 | Swift Plus Anterior Cervical Plate System | DePuy Spine, Inc. | KWQ | Class II | |
| K072543 | Onetouch Select Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K072526 | Micrus Courier Enzo Microcatheter 0.0190 | Micrus Endovascular Corporation | DQO | Class II | |
| K072525 | Zipknot, Model 1017-3000 | Medicinelodge, Inc. | FZP | Class II | |
| K072496 | Modification to Space Cpsxl Bone Cement | Dfine, Inc. | NDN | Class II | |
| K072438 | Medical Maggots, Creature Comforts | Monarch Labs, LLC | NQK | Unclassified | |
| K072233 | Skintact Multifunctional Electrodes with Dh02 Gel with Different Connectors Compatible with Different Defibrillators | Leonhard Lang GmbH | MKJ | Class III | |
| K072230 | Powerpicc Solo | C.R. Bard Inc | LJS | Class II | |
| K072229 | Monoswift | Cp Medical | GAM | Class II | |
| K072204 | Advia Chemistry Microalbumin Calibrators, _2 Calibrators | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model Crc; Cashmere-Sr, Model Src | Micrus Endovascular Corporation | HCG | Class II | |
| K072155 | Pioneer Catheter | Medtronic, Inc. | PDU | Class II | |
| K072117 | Thrombix Patch Thrombin Hemostasis Patch | Vascular Solutions LLC | QSX | Unclassified | |
| K072087 | Belimed Steam Sterilizer Model Top 5000 Series 24 | Belimed Sauter AG | FLE | Class II | |
| K072072 | Harmony LED-1 Surgical Lighting System | STERIS Corporation | FSY | Class II | |
| K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | NHA | Class II | |
| K071907 | Vcare Retractor/elevator | ConMed Corporation | LKF | Class II | |
| K071880 | Optima ZS Transition Screw | Zimmer Spine, Inc. | MNI | Class II | |
| K071879 | Zimmer Dto Implant | Zimmer Spine, Inc. | NQP | Class II | |
| K071511 | Plexus Herpeselect 1 and 2 Igg (with Plexus Tm Software), Model Mp0900g | DiaSorin Molecular LLC | MXJ | Class II | |
| K071347 | Vax-D Genesis G2 System | Vax-D Medical Technologies, LLC | ITH | Class II | |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and Abtrol | Thermofisher Scientific Oy | KHS | Class II | |
| K071160 | Reflection, Tandem Unipolar | Smith & Nephew, Inc. | LPH | Class II |