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 |
|---|---|---|---|---|---|
| K002581 | Duragard Sodium Fluoride Varnish | Sultan Dental Products, Ltd. | LBH | Class II | |
| K002547 | Starion Instruments Power Point Cautery Grasper/dissector | Microline Surgical, Inc | HQP | Class II | |
| K002423 | Lactosorb Push Screw | Zimmer GmbH | DZL | Class II | |
| K002229 | Wackers-Liu Cq Software | Eclipse Systems, Inc. | KPS | Class II | |
| K001646 | Puritan-Bennett 840 Ventilator System with Neomode Option | Medtronic, Inc. | CBK | Class II | |
| K000963 | Da Vinchi EEG and Emg/ep Systems | Airsep Corp. | GWF | Class II | |
| K000246 | Radiocameras Extracranial System | Surgical Navigation Technologies, Inc. | IYE | Class II | |
| K003225 | Solution Administration Sets with Capless Luer Activated Valve | Baxter Healthcare Corporation | FPA | Class II | |
| K003107 | M2376a Devicelink System | Agilent Technologies, Inc. | MWI | Class II | |
| K003010 | Spirit Acupuncture Needle | united pacific Company | MQX | Class II | |
| K002933 | Sterile Sensicare Synthetic Polyisoprene Powder-Free Surgical Gloves | Maxxim Medical | KGO | Class I | |
| K002905 | Access Thyroglobulin Reagents on the Access Analyzer | Siemens Healthcare Diagnostics Inc. | MSW | Class II | |
| K002663 | Hardydisk Netilmicin, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K002645 | Jel Bios Pure | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K002613 | Modification to Stat Profile Phox Plus Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K002566 | Lumalite Cure Light, Model 2100 | Lumalite, Inc. | EBZ | Class II | |
| K002519 | Vitrea 2, Version 2.1 | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K002479 | Biomesh P1 and Biomesh Plug and Patch | Cousin Biotech S.A.R.L | FTL | Class II | |
| K002471 | Jetcan Huber Neeedle Set | Pfm Produkte Fur die Medizin AG | FPA | Class II | |
| K002359 | Mdi Gliadin G Test | Micro Detect, Inc. | MST | Class II | |
| K002358 | Mdi Gliadin a Test | Micro Detect, Inc. | MST | Class II | |
| K002257 | Tecno Disposable Fingerswitch Pencil, Model 150-100 | Tecno Instruments (Pvt.) Ltd. | GEI | Class II | |
| K002189 | Gliadin Igg Antibody Eia Detection System | Scimedx Corp. | MST | Class II | |
| K002169 | Gliadin Iga Antibody Eia Detection System | Scimedx Corp. | MST | Class II | |
| K001795 | The Avitro Llc, 10 and 100 Uso Units/ml Heparin Sodium Vafd | Avitro, LLC | FOZ | Class II | |
| K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | MNH | Class II | |
| K001552 | Trepchek Treponemal Antibody Eia | Phoenix Biotech Corp. | LIP | Class II | |
| K000730 | Impoaid | Impoaid, Inc. | LKY | Class II | |
| K000696 | Macroporemx Mandibular Fixation System | Macropore Biosurgery, Inc. | JEY | Class II | |
| K000632 | 0.9% Sodium Chloride Vasculat Access Device | Avitro, LLC | FOZ | Class II | |
| K003090 | Midmark Procenter Instrument Delivery System | Midmark Corp | EIA | Class I | |
| K002967 | M2376a Devicelink System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K002957 | Solar Spo2 Module with Masimo Set | General Electric Medical Systems Information Techn | DQA | Class II | |
| K002921 | Sureone Insulin Syringe | Hosuk Co., Ltd. | FMF | Class II | |
| K002849 | Precisionedge-Acc, Precisionedge-Acs, Precisionedge-Lsk, and Precisionedge-Cb Microkeatome Blades | Surgical Specialties Corp | HNO | Class I | |
| K002700 | Ksea Unimat 12 | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K002686 | Achieva Ventilator Y-Ach+e, Achieva Ps Ventilator Y-Achps+e, Achieva Pso2 Ventilator Y-Achps02+e | Medtronic, Inc. | CBK | Class II | |
| K002534 | Eupalamus Deflectable Stylet, Model 01545 | Eupalamus, LLC | DRB | Class II | |
| K002510 | Smartlens | Odc Ophthalmic Development Co. AG | HKX | Class II | |
| K002444 | Precision Dosimetry Electrometer, Model 1010 or 206 | Sun Nuclear Corporation | IYE | Class II | |
| K002443 | Collagen Wound Dressing | Oasis Research, LLC | KGN | Unclassified | |
| K002330 | Navigus Peel Away Introducer | Image-Guided Neurologics, Inc. | GWG | Class II | |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265V | Pace Medical | DTE | Class II | |
| K001522 | Transq3 | Iomed, Inc. | KTB | Class II | |
| K000855 | Gunther Tulip Vena Cava Mreye Filter Set | Cook Inc. | DTK | Class II | |
| K994121 | Small Stature Uss | Synthes (USA) Products LLC | MNI | Class II | |
| K002936 | Modification to Ids5 Image Display System | Sectra-Imtec AB | LLZ | Class II | |
| K002913 | Headband for Baha | Entific Medical Systems, Inc. | LXB | Class II | |
| K002898 | Curon Control Module Electrosurgical Generator and Accessories, Model S500-St | Curon Medical, Inc. | GEI | Class II | |
| K002828 | Xps Nitro System | Xomed, Inc. | ERL | Class II |