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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K223073 | Alio | Alio, Inc. | DRG | Class II | |
| K222101 | Prism | Graymatters Health | HCC | Class II | |
| K221965 | FemDx FalloView | Femdx Medsystems, Inc. | MKO | Class II | |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy-America, Inc. | FJL | Class II | |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte., Ltd. | DRS | Class II | |
| K221772 | NeuroRPM | New Touch Digital, Inc. | GYD | Class II | |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.p.A. | PKC | Class II | |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | Tonica Elektronik a/S | HAW | Class II | |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | DiaSorin Molecular LLC | QOF | Class II | |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | BioFire Diagnostics, LLC | PCH | Class II | |
| K223828 | BENCOX Delta Option Heads | Corentec Co., Ltd. | LZO | Class II | |
| K223393 | Electric Wheelchair | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Inc. | OBP | Class II | |
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K223084 | MilkMate Breast Pump | Milkmate Products, Inc. | HGX | Class II | |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | Intuitive Surgical, Inc. | NAY | Class II | |
| K222838 | iSyncBrain©-C | Imedisync Inc. | OLU | Class II | |
| K222813 | Nitrile Examination Gloves | Ecoglove Medical Manufacturing Company Limited | LZA | Class I | |
| K222619 | Ensmile | Ensmile Pvt, Ltd. | NXC | Class II | |
| K220673 | Sterile Silver Alginate Wound Dressing | Qingdao Bright Moon Biomedical Materials Co Ltd | FRO | Unclassified | |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K223760 | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn Inc | HKI | Class II | |
| K223375 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. | Kossan International Sdn Bhd3 | LZA | Class I | |
| K223102 | Tegamen Nitrile Examination Gloves | M/S Tegamen Safety Products Private Limited | LZA | Class I | |
| K222991 | Air Compression Leg Massager (model: EMK-701) | Xiamen Emoka Health Science and Technology Company Limited | IRP | Class II | |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Monteris Medical Corp | GEX | Class II | |
| K221924 | Digital Routines | Gnc Holdings, LLC | NDC | Class II | |
| K220234 | Precice Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K220122 | Apex 6 | Rf Innovations, Inc. | GXD | Class II | |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Biomet Manufacturing Corp | PHX | Class II | |
| K230145 | One-Cuf | GE Medical Systems Information Technologies, Inc. | DXQ | Class II | |
| K230019 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K223753 | Cervical Plate System | Double Medical Technology Inc. | KWQ | Class II | |
| K223609 | RevCore™ Thrombectomy Catheter. | Inari Medical, Inc. | QEW | Class II | |
| K223464 | Leg and Foot Air Wave Pressure Therapy Device | Zhangzhou Easepal Innovation Co.,Ltd | IRP | Class II | |
| K223279 | RT Elements (4.0) | Brainlab, Inc. | MUJ | Class II | |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty), Ltd. | QUH | Class II | |
| K213247 | JETT PLASMA Medical II | Compex, Spol, s.r.o. | QVJ | Class II | |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | DQD | Class II | |
| K223350 | Remi Robotic Navigation System | Fusion Robotics, LLC | OLO | Class II | |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical | KWQ | Class II | |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | Innova Vision Inc. | LPL | Class II | |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K221352 | Surgical Face Mask | Wuhan Huashida Protective Products Co., Ltd. | FXX | Class II | |
| K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | FYA | Class II | |
| K230433 | Arthrex Knotless FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K230349 | Lyra RSV+hMPV Assay | Ortho-Clinical Diagnostics, Inc. | OEM | Class II | |
| K230295 | ATTUNE® Revision Cones | Depuy Ireland UC | MBH | Class II |