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 |
|---|---|---|---|---|---|
| K092389 | Disposal ECG Electrodes, Model Easyrode | Suzuken Co., Ltd. | DRX | Class II | |
| K091709 | Multi-Med Central Venous Catheters, Models: M3720hkic, M4820hkic | Edwards Lifesciences LLC | FOZ | Class II | |
| K090459 | Disposable Tpe Infusion Set | Shan Dong Wei Gao Group Medical Polymer Products | FPA | Class II | |
| K090017 | Carto 3 Ep Navigation System, V1.0 and Accessories | Biosense Webster Inc | DQK | Class II | |
| K092962 | Carotid Coil 5000004901 | Shanghai Chenguang Medical Technologies Co, Ltd | MOS | Class II | |
| K092948 | Aplio Mx Ssa-780A, Version 1.0 | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K092939 | Patlog 2.0 | Oncolog Medical QA AB | IYE | Class II | |
| K092810 | Ep-Workmate System, Version 4.2 | Abbott Medical | DQK | Class II | |
| K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model Kp-7770 | K-Jump Health Co., Ltd. | DXN | Class II | |
| K092770 | Simplygo Hands Free Breast Pump | Evenflo Company, Inc. | HGX | Class II | |
| K092757 | Theratest El-Beta2gpi (Igm-Igg-Iga), Theratest El--Beta2gpi Scr | Theratest Laboratories, Inc. | MSV | Class II | |
| K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips North America LLC | JAK | Class II | |
| K092650 | Heartway Power Mobility Scooter, S12 | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene Sp System (Rvnatsp) | Luminex Corporation | OCC | Class II | |
| K092513 | Rainbow Block | GENOSS Co., Ltd. | EIH | Class II | |
| K092432 | Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/l) | Jawon Medical Co., Ltd. | DXN | Class II | |
| K092297 | Eletone Cream | Ferndale Pharma Group, Inc. | FRO | Unclassified | |
| K092225 | Amypower All Track Series Power Wheelchair | Amylior, Inc. | ITI | Class II | |
| K092212 | Busse Surgical Drapes III | Busse Hospital Disposables | KKX | Class II | |
| K092182 | Voyager Compact Imaging System | Ardent Sound, Inc. | IYO | Class II | |
| K092109 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Zhangjiangang All Fine Rubber-Plastic Products Co. | LYZ | Class I | |
| K092105 | Radianalyzer Xpress | Radi Medical Systems AB | DQK | Class II | |
| K092103 | Dental Extraoral Source X-Ray System (Esx) | Vatech Co., Ltd. | EHD | Class II | |
| K092049 | Iyunni 3Id Tri-Funnel Gastrostomy Tube Kit | Sainath Intellectual Properties, LLC | KNT | Class II | |
| K091803 | Smarttrack System | Nexus6, Ltd. | CAF | Class II | |
| K091787 | Model 6000 Two Parameter Bedside Monitor | Ivy Biomedical Systems, Inc. | DQA | Class II | |
| K091767 | 3 Way Silicone Foley Balloon Catheter | Cook Incorporated | EZL | Class II | |
| K091758 | Bd Spinal Needle 27G | Becton Dickson & Co. | BSP | Class II | |
| K091623 | Laminoplasty Fixation System | NuVasive Inc | NQW | Class II | |
| K091584 | Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire | Merit Medical Systems, Inc. | DRE | Class II | |
| K091574 | Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical Sutures | Supplidores Unidos Internacionales, S.A. | GAT | Class II | |
| K091440 | Laparoscopic Resection Device, Model Sr326l | Apyx Medical Corporation | GEI | Class II | |
| K091216 | Clinitek Status+analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics Inc. | JIL | Class II | |
| K090991 | Computed Tomography X-Ray System, Model Picasso-Duo | E-Woo Technology | JAK | Class II | |
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | JWH | Class II | |
| K090653 | Pocketchem Ez Blood Glucose Monitoring System | Arkray Factory USA, Inc. | NBW | Class II | |
| K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | JOJ | Class II | |
| K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory Co. | GGN | Class II | |
| K090190 | Win-Neus Stereotactic Surgery Treatment Planning System | Nuclemed S.A. | HAW | Class II | |
| K083552 | Maxmorespine Tom Stick | Hoogland Spine Products GmbH | HRX | Class II | |
| K092949 | Imagegrid Radiology Viewer System | Candelis, Inc. | LLZ | Class II | |
| K092863 | Maxiflo, Taperflo | Vascutek, Ltd. | DSY | Class II | |
| K092834 | Hoffman Xpress Line Extension | Howmedica Osteonics Corp | KTT | Class II | |
| K092804 | Microselectron Hdr V2, Model 105.999 | Nucletron BV | JAQ | Class II | |
| K092763 | If True Sine Interferential Stimulator, Wl-2206D | Well-Life Healthcare Limited | LIH | Class II | |
| K092575 | Engage/engage Tr | Abbott Medical | DYB | Class II | |
| K092509 | Edwards Lifesciences Venous Return Cannulae | Edwards Lifesciences LLC | DWF | Class II | |
| K092431 | Body Composition Analyzer, Model: Ioi 353 | Jawon Medical Co., Ltd. | MNW | Class II | |
| K092253 | Modification to Fmri Hardware System | NordicNeuroLab AS | LNH | Class II | |
| K092204 | Pmd Viewer | Spencer Technologies | LLZ | Class II |