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 |
|---|---|---|---|---|---|
| K003229 | Biopatch Antimicrobial Dressing | Integra LifeSciences Corporation | SEL | Unclassified | |
| K001509 | Stockert V172 Series Venous Femoral Cannulae | LivaNova USA, Inc. | DWF | Class II | |
| K013272 | Acs: 180 and Advia Centaur Theophylline 2 Assay | Bayer Corp. | KLS | Class II | |
| K013230 | Cercon Base | Degussa - Ney Dental, Inc. | EIH | Class II | |
| K012997 | Collatek Foam | Biocore Medical Technologies, Inc. | MGP | Unclassified | |
| K012995 | Collatek Sheet | Biocore Medical Technologies, Inc. | MGP | Unclassified | |
| K012848 | Winner Cm4 Combination Unit | Rich-Mar Corp. | GZJ | Class II | |
| K012769 | Macropore ENT Reconstruction Film | Macropore Biosurgery, Inc. | NHB | Class II | |
| K012736 | Monoject Safety Needle | Tyco Healthcare | FMI | Class II | |
| K012717 | Life 2 | Sybron Dental Specialties, Inc. | EJK | Class II | |
| K012519 | Arthrocare Electrosurgery Wands | ArthroCare Corporation | GEI | Class II | |
| K012141 | Aecp-a, Automatic External Counterpulsation Device | External Counterpulsation Lab | DRN | Class II | |
| K011952 | Drugs of Abuse Multi-Test Strip | Microdiagnostics, Inc. | DKZ | Class II | |
| K011318 | Venodyne Dvt Advantage Plus | Microtek Medical LLC | JOW | Class II | |
| K011046 | Autopulse, Model 100 | Revivant Corp. | DRM | Class II | |
| K002632 | Oxygenator | Adjunctive Therapeutics, Inc. | KPJ | Class II | |
| K013290 | Modified 650 Mammography System | Hologic, Inc. | IZH | Class II | |
| K013191 | Pass Spinal System | Encore Orthopedics, Inc. | MNI | Class II | |
| K013147 | Glucose Control Solution for Therasense Freestyle | Bionostics, Inc. | JJX | Class I | |
| K012990 | Collatek Powder | Biocore Medical Technologies, Inc. | KGN | Unclassified | |
| K012909 | Xterra Gt Power Wheelchair | Invacare GmbH | ITI | Class II | |
| K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 | Boston Scientific Corporation | FCG | Class II | |
| K012832 | Comfortmate Fluid Warming System, Model # Fw-200; Comfortmate Disporsable Disposable Warming Set, Model #Fws-200 | NxStage Medical Inc | LGZ | Class II | |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-Xxx | Boston Scientific Corporation | FGE | Class II | |
| K012792 | C.t.m. Mobitiy Scooter Model #Hs-360 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K012791 | C.t.m. Mobility Scooter Model # Hs-320 | Warepalmy Enterprise, LLC (USA) | INI | Class II | |
| K012673 | Prime-Dent One-Step Orthodontic Adhesive Bonding System | Prime Dental Manufacturing, Inc. | DYH | Class II | |
| K012491 | Machnet Carotids Coil Array Assembly | Machnet BV | MOS | Class II | |
| K012475 | Caas II Qva | PIE Medical Imaging B.V. | LLZ | Class II | |
| K012419 | Conform Sheeting, Model Igel | Implantech Associates Inc | MDA | Class I | |
| K012143 | 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524 | Medtronic Cardiac Surgical Products | DRA | Class II | |
| K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | MEG | Class II | |
| K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or Ptd | Arrow Intl., Inc. | QEW | Class II | |
| K010930 | Lift Vb Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K001974 | Ez-on Condom | Mayer Laboratories | MOL | Class II | |
| K000741 | Ems Jumper II Dual Channel Neuromuscular Stimulator System, Model E-188 | 138 Medical Supplies, Inc. | IPF | Class II | |
| K013325 | Point 4 Flowable 2 | Kerr Dental Materials Center | EBF | Class II | |
| K013202 | Modification to Braided Guiding Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K013033 | Modification to: Hl168w Touch Screen | Health & Life Corporation | DXN | Class II | |
| K012840 | Euro 45, Order-No.: 2064 | Wieland Edelmetalle GmbH & Co. | EJS | Class II | |
| K012838 | Ero50, Order-No.: 2070 | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K011058 | Telepress III Blood Pressure Monitor, Model Tpiii | Meridian Medical Technologies, Ltd. | DXN | Class II | |
| K010053 | Humi-Flow, Model 6-850-00/ 01/02 | Northgate Technologies Inc. | HIF | Class II | |
| K013277 | Astralis 7, Model 557545 | Ivoclar Vivadent, Inc. | EBZ | Class II | |
| K013237 | Statusblue | Dmg USA, Inc. | ELW | Class II | |
| K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems | CHH | Class I | |
| K013059 | Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures) | Stony Brook Surgical Innovations, Inc. | GAQ | Class II | |
| K012955 | Coaptite Tissue Marker and Coaptite Fn Tissue Marker | Bioform, Inc. | NEU | Class II | |
| K012821 | D.o.r.c. Cryostar Cryosurgical System | Dutch Ophthalmic USA, Inc. | HRN | Class II | |
| K012777 | Acs: 180 and Advia Centaur Anti-Thyroglobulin Immunoassays | Bayer Corp. | JZO | Class II |