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 |
|---|---|---|---|---|---|
| K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K080122 | Sopro 670 Arthroscopic Pump | Sopro | HRX | Class II | |
| K080047 | Cardiosen'c | SHL TeleMedicine International | DXH | Class II | |
| K073581 | Ici P and S Series Ir Cameras | Texas Infrared | LHQ | Class I | |
| K073555 | Insulin Protector | Medicool, Inc. | IQG | Class I | |
| K071810 | Inion Spinal Graft Containment System | Inion Oy | OJB | Class II | |
| K071677 | Srt II Muscle Stimulator | Therapeutic Innovations, Inc. | IPF | Class II | |
| K081794 | Model 7340 Ultrasound System | Esaote S.p.A. | IYN | Class II | |
| K081680 | Nucleus-X, Model 230X | Numed Inc | DQY | Class II | |
| K081669 | Improved Comfort-Fit Nightguard | Den Tek Oral Care, Inc. | OBR | Unclassified | |
| K081345 | Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) | ThermoGenesis Corp. | JQC | Class I | |
| K081273 | Ultracaps S | Sdi, Ltd. | OIV | Class II | |
| K081039 | Lipo Cannula | Millennium Medical Technologies, Inc. | QPB | Class II | |
| K080778 | Ensplint Tm Bone Screw | Sonoma Orthopedic Products, Inc. | HWC | Class II | |
| K080739 | Abbott Realtime Ct/ng Assay and Multi-Collect Specimen Collection Kit | Abbott Molecular, Inc. | MKZ | Class I | |
| K080200 | Water Works Douching Device | Abbott Research Group, Inc. | HED | Class I | |
| K073678 | Variosurg | Nakanishi Inc. | DZI | Class II | |
| K073383 | Well Lead Reinforced Endotracheal Tube | Well Lead Medical Instruments | BTR | Class II | |
| K073074 | Key Laser III 1243 US with Detect | Kavo America | GEX | Class II | |
| K081781 | Nuwav | Abbott Medical | IYO | Class II | |
| K081356 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | HSB | Class II | |
| K081329 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | NLH | Class II | |
| K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corporation | LZA | Class I | |
| K080804 | Busse Plastic Lor Syringe | Busse Hosipital Disposables | CAZ | Class II | |
| K080797 | Humidaire 2I | ResMed Corp | BTT | Class II | |
| K080689 | Spectra Therapy System A1000 Laser Device | Premier Dynamics, Inc. | ILY | Class II | |
| K080642 | Comprehensive Reverse Shoulder | Zimmer GmbH | PHX | Class II | |
| K080097 | Medtrade Products Celox Hemostatic Granules on Sheet | Medtrade Products Ltd. | QSY | Unclassified | |
| K073341 | Genex Putty | Biocomposites, Ltd. | MQV | Class II | |
| K070779 | Sonatherm 600I Ultrasonic Lesion Generating System | Misonix, LLC | NTB | Class II | |
| K081015 | Ceralas D 980Nm Diode Laser, Models D15 and D25 | Biolitec, Inc. | GEX | Class II | |
| K080672 | Birthtrack | Barnev, Ltd. | NPB | Class II | |
| K080647 | Accin Bipolar Head System | Accelerated Innovation, LLC | KWY | Class II | |
| K081683 | Loci Cardiac Troponin I Calibrator, Model Rc621 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K081043 | Leak Detection Sensor and Tray Accessory Kit | NxStage Medical Inc | KOC | Class II | |
| K080496 | Mosaic Eco2 Laser System | Lutronic Corporation | GEX | Class II | |
| K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | LLZ | Class II | |
| K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, Rf621, Kd692 | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K081598 | Suture Lock Nail Bone Anchor with White (Kfx-W-200) & Blue (Kfx-B-200) Fiberforce Suture | Kfx Medical | MBI | Class II | |
| K081567 | Vertebron Ssp Cervical Plating System | Vertebron, Inc. | KWQ | Class II | |
| K081391 | Vip Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K081373 | Evolve Eps System | Wrightmedicaltechnologyinc | HRS | Class II | |
| K081158 | Zodic Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | MNI | Class II | |
| K080972 | Echelon Zebra Cartridges, Models, Z45wb, Z45bg, Z45gp, Z60wb, Z60bg, Zp60gp | Ethicon Endo-Sugery, LLC | GDW | Class II | |
| K080538 | Ideal Life Pod (Model Ilp 0001) | Ideal Life, Inc. | NBW | Class II | |
| K080451 | Uniblate Electrosurgical Device | Boston Scientific Corporation | GEI | Class II | |
| K080287 | Oncobionic Bipolar Electrode | Boston Scientific Corporation | GEI | Class II | |
| K080224 | Klockner Essential Dental Implants System, Models Essential Cone (Ec), Essential Solid (Es) and Eck | Soadco, S.L. | DZE | Class II | |
| K080199 | Symmetric Total Knee System | Whiteside Biomechanics, Inc. | JWH | Class II | |
| K073693 | Costorsol | Preservation Solutions Inc | KDN | Class II |