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 |
|---|---|---|---|---|---|
| K001802 | Venodyne Dvt Advantage Model 610 | Microtek Medical LLC | JOW | Class II | |
| K000560 | Synthes (USA) Resorbable Tack System | Synthes (USA) Products LLC | JEY | Class II | |
| K990800 | Intergard Knitted Ultra Thin and Intergard Knitted Collagen Coated and Heparin Bonded Vascular Prothesis | Intervascular, Inc. | DSY | Class II | |
| K003925 | Prowler Infusion Catheters with Pre-Shaped Tips | Cordis Neurovascular, Inc. | KRA | Class II | |
| K003827 | Punctur-Guard Winged Set for Blood Collection | Bio-Plexus, Inc. | FMI | Class II | |
| K003822 | Isola Closed Dual Rod Connector | Depuyacromed | KWP | Class II | |
| K003339 | Collagen Periodontal Membrane | Collagen Matrix, Inc | NPL | Class II | |
| K003334 | Stick Net | Stick Tech Ltd. | EBI | Class II | |
| K003227 | Bio-Absorbable Corkscrew Model Ar-1920B | Arthrex GmbH | MAI | Class II | |
| K003164 | Trocars Trotec with Automatic Protective Mechanism | Richard Wolf Medical Instruments Corp. | HET | Class II | |
| K003151 | Micropobe Series of Lasers and Accessories | Endooptiks, Inc. | GEX | Class II | |
| K002915 | Flexible Occlusion System | Applied Medical | DXC | Class II | |
| K002717 | Sterile Piston Syringe | Abbott Medical | FMF | Class II | |
| K002603 | Zynergy Balloonpace Balloon Guided Pacing and Monitoring Catheter | Zcv,Inc. | LDF | Class II | |
| K001896 | Kenz ECG 108 Single Channel Digital Electrocardiographs; Kenz ECG 110 Single Channel Digital Electrocardiographs with Ec | Suzuken Co., Ltd. | DPS | Class II | |
| K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | |
| K003956 | Bard Endocinch Suturing System # 000452; 000454; 000595 | C.R. Bard Inc | ODE | Class II | |
| K003793 | Bard Luminexx Biliary Stent | C.R. Bard Inc | FGE | Class II | |
| K003768 | Monarch II IOL Delivery System | Alcon Laboratories | MSS | Class I | |
| K003763 | 2010 Plus Holter for Windows | Agilent Technologies, Inc. | MLO | Class II | |
| K003292 | 260 Corvus | Pie Medical | IYO | Class II | |
| K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil Temperature-Sensing Foley Catheter (Lu | C.R. Bard Inc | EZL | Class II | |
| K003154 | Mizar, Basis Be, Sandman Digital | EB Neuro S.p.A. | GWL | Class II | |
| K003031 | Lensoclean Multi-Purpose Solution, Model 355Ml | Alpha Vista, Inc. | LPN | Class II | |
| K002488 | Kelo-Cote Topical Gel | Advanced Bio-Technologies, Inc. | MDA | Class I | |
| K003898 | Ebi Vuecath Spinal Endoscopic System | Ebi, LLC | HRX | Class II | |
| K003832 | Sulzer Orthopedics Anatomical Shoulder Cemented Humeral Stem | Sulzer Orthopedics, Inc. | KWS | Class II | |
| K003753 | Gp General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, Gp General Purpose Drainage Cathe | Uresil, LLC | FGE | Class II | |
| K003658 | Temp-Bond Ne 2 | Sybron Dental Specialties, Inc. | EMA | Class II | |
| K003498 | Fresenius Optiflux 200A | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K003462 | Erbe Apc Handle and Applicators, Model 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 | Erbe USA Inc | GEI | Class II | |
| K003367 | Orion Platinum | Srs Medical Systems, Inc. | HCC | Class II | |
| K003333 | Stick | Stick Tech Ltd. | EBI | Class II | |
| K003330 | Aktina Medical Physics Corporation Active Breathing Coordinator (Abc) | Aktina Medical Physics Corp. | IYE | Class II | |
| K003269 | Unicondylar Interpositional Spacer | Sulzer Orthopedics, Inc. | HSH | Class II | |
| K003176 | Bioemg II and Biojva | Bio-Research Associates, Inc. | KZM | Class II | |
| K003155 | Vertebral Body Replacement | Osteotech Inc | MQP | Class II | |
| K003127 | Regain Desktop | Srs Medical Systems, Inc. | HCC | Class II | |
| K003111 | Stryker Navigation System-Spine & Fluoroscopy Modules | Stryker Corp. | HAW | Class II | |
| K002932 | Phacogard | Syntec, Inc. | HQC | Class II | |
| K002863 | Palfique Estelite Lv | Tokuyama America Inc. | EBF | Class II | |
| K002513 | Astra Tech Implants - Dental System | Astra Tech, Inc. | DZE | Class II | |
| K002269 | Electrosurgical Probes and Devices-Geltx | Ximed/Prosure/Injectx | GEI | Class II | |
| K003756 | Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates | Bionx Implants, Inc. | JEY | Class II | |
| K003729 | Ultimum Ev Hemostasis Introducer (14F), Ultimum Ev Hemostasis Introducer (16F), Ultimum Ev Hemostasis Introducer (18F), | Abbott Medical | DYB | Class II | |
| K003415 | Aneroid Sphygmomanometer with Stethoscope | Wang & Li, Inc. | DXQ | Class II | |
| K994292 | Water Purification System | Water & Power Technologies, Inc. | FIP | Class II | |
| K003764 | Modification to Ebi Spinelink System | Ebi, LLC | MNH | Class II | |
| K003563 | Powder-Free Nitrile Exam Glove, Lavender/purple | Ning BO Yujiang Rubber & Plastic Co. | LZA | Class I | |
| K003509 | Flexicast | American Dent-All, Inc. | EJH | Class II |