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 |
|---|---|---|---|---|---|
| K081715 | Fora Td-4244 & Td-4245 Blood Glucose Monitoring Systesm | Taidoc Technology Corporation | NBW | Class II | |
| K081498 | Tenso-Comfort Blood Pressure Meter, Models Bpm 105 and Bpm 205 | Biocomfort Diagnostics GmbH & Co. KG | DXN | Class II | |
| K081412 | Plum a+ Hyperbaric Infusion System with Hospira Mednet Software | Abbott Medical | FRN | Class II | |
| K081165 | Ellipse Lumbar Posterior Osteosynthesis System | Spineart SA | MNH | Class II | |
| K080794 | Polyvue 55 Single Vision, Toric and Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear | Polyvue Distribution, Inc. | LPL | Class II | |
| K080458 | Mis Crest Widener | Mis - Implant Technologies, Ltd. | MQN | Class II | |
| K083555 | Picture Archiving and Communication System (Pacs), Petavision | Emsoma Co., Ltd. | LLZ | Class II | |
| K083538 | Neurostar Tms Therapy System, Model 1.1 | Neuronetics Inc. | OBP | Class II | |
| K083272 | Skinclear Q-Switched Nd:yag Laser | Global USA Distribution, LLC | GEX | Class II | |
| K083171 | Introl Cf Panel I Control, Model: G106 | Maine Molecular Quality Controls, Inc. | NZB | Class II | |
| K083164 | System-Arms, Models 390, X60 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K083137 | Neuro III-Sv | Imris, Inc. | LNH | Class II | |
| K083070 | Toggleloc System | Biomet Sports Medicine | MBI | Class II | |
| K083063 | Bis Interface for Vitalogik Patient Monitors | Mennen Medical, Inc. | OLW | Class II | |
| K082724 | Newport Hts50 Ventilator with Dual Pac Battery System | Newport Medical Instruments, Inc. | CBK | Class II | |
| K082451 | Stryker Videoscope | Stryker Corp. | HET | Class II | |
| K082424 | United U2 Total Knee System | United Orthopedic Corp. | JWH | Class II | |
| K082278 | Mammomark, Mammomark Mr and Cormark Biopsy Site Identifiers | Ethicon Endo-Sugery, LLC | NEU | Class II | |
| K082210 | Total Bilirubin L3k, Model 295-10 and 295-30 | Genzyme Diagnostics P.E.I., Inc. | CIG | Class II | |
| K081929 | Vacuette Blood Collection Tube with Clot Activator and Gel Separator | Greiner Bio-One North America, Inc. | JKA | Class II | |
| K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc | GEI | Class II | |
| K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | DXH | Class II | |
| K083402 | Agilis Nxt Steerable Introducer, Model G408322 and G408323 | Abbott Medical | DYB | Class II | |
| K083335 | Modified Omniwave Endovascular System | Omnisonics Medical Technologies | QEY | Class II | |
| K083211 | Airseal Optical Trocar & Cannula System | Surgiquest, Inc. | GCJ | Class II | |
| K083202 | Combocare 2000 | Xanacare Technologies, LLC | GZJ | Class II | |
| K083129 | Sharps Compliance Container | Sharps Compliance, Inc. | MMK | Class II | |
| K083093 | Cheetah Reliant | Cheetah Medical, Inc. | DSB | Class II | |
| K082755 | Sedat Flamingo | Sedat | MAV | Class II | |
| K082705 | Biopro Bipolar Head, Models 18130-18152 | Biopro, Inc. | KWY | Class II | |
| K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | MNH | Class II | |
| K082460 | Cenefom Pva Surgical Spear | Longtek Scientific Co., Ltd. | HOZ | Class II | |
| K082355 | Visionsense Stereoscopic Vision System | Visionsense, Ltd. | HRX | Class II | |
| K082224 | Diagnostic Ultrasound System Sarano, Echo View, Shimasonic | Shimadzu Medical Systems | ITX | Class II | |
| K080542 | Distrax | John W. King | MQN | Class II | |
| K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | KRD | Class II | |
| K083505 | Dc-3/Dc-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K083504 | Ge Discovery Nm/ct 570C | GE Medical Systems F.I. Haifa | KPS | Class II | |
| K083440 | Primatrix Dermal Repair Scaffold | Integra LifeSciences Braintree Inc. | KGN | Unclassified | |
| K083379 | Cynosure Smartlipo Mpx Laser with Smartsense C Module | Cynosure, LLC | GEX | Class II | |
| K083370 | D-Clot Thrombectomy Catheter System, Model: Dc 4006 | Artegraft, Inc. | QEW | Class II | |
| K083282 | Model Tsx-301B Aquilion CT System | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K083044 | Hubang, Model Hbl13/hbg12-S | Shanghai Hubang Medical Appliances Co., Ltd. | IOR | Class I | |
| K082970 | Marvel Wheelchair, Model Edcal01 | Rogue Wheels, Inc. | IOR | Class I | |
| K082932 | Cps Aim Sl Slittable Inner Catheter | Abbott Medical | DQY | Class II | |
| K082795 | Single Use Perpos Pls System, 4.5 Bone-Lok Pls Implant | Interventional Spine, Inc. | MRW | Unclassified | |
| K082673 | Conserve Pressfit Femoral Component | Wrightmedicaltechnologyinc | KXA | Class II | |
| K082603 | Trimira Ocs 3000 | Remicalm, LLC | NXV | Class II | |
| K082416 | Iba Proton Therapy System- Proteus 235 | Ion Beam Applications S.A. | LHN | Class II | |
| K082382 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | Possis Medical, Inc. | QEZ | Class II |