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 |
|---|---|---|---|---|---|
| K003268 | Z-Touch | Brainlab, Inc. | HAW | Class II | |
| K003260 | Vectorsurge 4 Interferential Therapy Unit Model Vs 460 | Metron Medical Australia, Pty, Ltd. | IPF | Class II | |
| K002758 | Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175a/76a | Agilent Technologies Deutschland GmbH | DSI | Class II | |
| K002515 | Medlogics Ml 4000, Model 4000 | Med-logics Inc | HNO | Class I | |
| K002079 | Multi-Function Defibrillation Electrode | Medicotest, Inc. | MKJ | Class III | |
| K001631 | Cortex Metamax | Cortex Biophysik GmbH | BZC | Class II | |
| K991259 | Te Me Na Epidural Catheter | Te ME NA S.A.R.L. | BSO | Class II | |
| K010374 | Sonosite Hand-Carried Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K010228 | Gore-Tex Dualmesh Plus Biomaterial with Holes | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K010219 | Challenger Direct Composite | International Dental Research | EBF | Class II | |
| K010210 | Control Module Algorithm Enhancement for the Model S500-St and Model S400 | Curon Medical, Inc. | GEI | Class II | |
| K004000 | Ocu-Flex-49 Thin Zone Toric and Thin Z0ne Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily Wear (Lathe-Cut | Ocu-Ease Optical Products, Inc. | LPL | Class II | |
| K003996 | Ocu-Flex-53 Thin Zone Toric and Thin Zone Toric Aspherical (Ocufilcon) Soft Contact Lenses for Daily Wear | Ocu-Ease Optical Products, Inc. | LPL | Class II | |
| K003912 | Phosphorus Reagent | JAS Diagnostics/Drew Scientific | CEO | Class I | |
| K003882 | Nucamma Bi90 | Is2 Research, Inc. | KPS | Class II | |
| K003856 | Ez-Hcg Urine(pregnancy Test) | Biomerica | JHI | Class II | |
| K003792 | Stryker Heated Insufflator Tube Set | Stryker Corp. | HIF | Class II | |
| K003789 | Speciality 56 UV (Hefilcon C) Soft (Hydrophillic) Contact Lens for Daily Wear; Speciality 56 UV Toric (Hefilcon C) Soft | Specialty Ultravision, Inc. | LPL | Class II | |
| K003651 | Aurora | Aurora Imaging Technology, Inc. | LNH | Class II | |
| K003507 | Medrelief | Healthonics, Inc. | GZJ | Class II | |
| K003332 | Meditherm Med2000 | Meditherm Inc. | LHQ | Class I | |
| K003252 | Complete Brand Multi-Purpose Solution | Allergan | LPN | Class II | |
| K002912 | Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073 | Sterinc | HIB | Class II | |
| K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | FRO | Unclassified | |
| K001852 | Peripheral Arterial Tonometer-Pat 1000Rd Device | Itamar Medical (C.M.) 1997, Ltd. | DQK | Class II | |
| K010208 | Dimension Enzymatic Carbonate (Eco2) Calibrator, Catalog Dc137 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K003892 | Total Bilirubin Reagent | Intersect Systems, Inc. | CIG | Class II | |
| K003870 | Thromborel S | Siemens Healthcare Diagnostics Inc. | GJS | Class II | |
| K003700 | Synthes Hamstring Loop | Synthes (USA) Products LLC | HWC | Class II | |
| K003659 | Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 | Bionx Implants, Inc. | HTY | Class II | |
| K003612 | Microspeed Ec Motorsystem Gd650/gd653 | Aesculap Inc | HBC | Class II | |
| K003608 | Sovereign Bipolar Instruments for Gynecology | Aesculap Inc | HGI | Class II | |
| K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Ltd. | FLE | Class II | |
| K010336 | Advantage Windows Ct/pet Fusion | GE Healthcare | LLZ | Class II | |
| K010297 | Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene) | Maxxim Medical | LZA | Class I | |
| K010135 | Models Lynx and Panther Motorized Scooters, Models Lynx Sx-3, Lynx Sx-3P, Lynx Lx-3, Lynx Lx-3, Panther Lx-4 | Invacare GmbH | INI | Class II | |
| K003933 | Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy | Polymer Technology Corp. | MUW | Class II | |
| K003932 | Boston Eo (Enflufocon B) Contact Lens for Orthokeratolgy | Polymer Technology Corp. | HQD | Class II | |
| K003755 | Medline Blockade or Resistat Surgical Gowns and Surggical Drapes | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K003130 | Regutherm 952 Thermographic System | Sie-Med, Inc. | LHQ | Class I | |
| K002650 | Van Andle Dilation, Emerald Guidewire, Model Vad6, 502-726 | Bentec Medical, Inc. | FGE | Class II | |
| K002466 | Acticoat Composite Dressing | Westaim Biomedical, Inc. | FRO | Unclassified | |
| K002054 | X-Sept Transseptal Sheath and Transition Catheter, Model Mv-03-09-90, Mv-03-10-90, Mv-03-11-90, Mv-03-09-120, Mv-03-10-1 | Appriva Medical, Inc. | DYB | Class II | |
| K002045 | Water Purification System for Hemodialysis | Total Water Treatment Systems, Inc. | FIP | Class II | |
| K001916 | Compat Replacement Gastrostomy Tube Kit, Model 0974Xx | Novartis Nutrition Corp. | KNT | Class II | |
| DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies Corporation | NDS | Class II | |
| K010243 | Tri-Fit Femoral Stem | Corin USA | LWJ | Class II | |
| K010211 | Sterile Nitrile Powder-Free Examination Gloves | Medtronic, Inc. | LZC | Class I | |
| K010194 | Comfor-Cliner | Recliner Care, Inc. | IOR | Class I | |
| K010094 | A & I Wheelchairs | Taiwan an I Co., Ltd. | IOR | Class I |