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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K232589 | Horos MD™ | Icat Solutions Ltd | LLZ | Class II | |
| K231779 | REMI AI Discrete Detection Module | Epitel | OMB | Class II | |
| K231707 | ResQ Administration Set | Q for Plastic Industries | FPA | Class II | |
| K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | LGM | Class II | |
| K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun Ltd. | LPL | Class II | |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | ONG | Class II | |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Alcon Laboratories | LPL | Class II | |
| K233790 | Acl Top 970 Cl | Instrumentation Laboratory Co. | JPA | Class II | |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | HIR | Class II | |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | OBP | Class II | |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | IYO | Class II | |
| K230438 | URIS Smart Path Implant System & Prosthetic | TruAbutment Inc. | DZE | Class II | |
| K223714 | UniFit Dental Implant System | Adin Dental Implant Systems Ltd. | DZE | Class II | |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Gotzen S.r.l. | EHD | Class II | |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | GZI | Class II | |
| K230985 | Planmeca Viso | Planmeca Oy | OAS | Class II | |
| K230891 | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium MedTech Limited | MBI | Class II | |
| K230006 | Ankyras | Mentice Spain S.L. | PZO | Class II | |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | DQY | Class II | |
| K232756 | Colibrí | Copan WASP | LON | Class II | |
| K232518 | EndoSound Vision System; EVS | Endosound Inc | ODG | Class II | |
| K231914 | Nurochek-II System | Headsafe Mfg Pty Ltd | PIW | Class II | |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | |
| K233659 | Suture Wing | Osteonic Co., Ltd. | MBI | Class II | |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | NQJ | Class II | |
| K233300 | POWEReam 1/4 Drive | Stryker Corp. | NKB | Class II | |
| K232937 | Btl-899M | BTL Industries, Inc | IPF | Class II | |
| K231130 | TumorSight Viz | Simbiosys, Inc. | QIH | Class II | |
| K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | DYH | Class II | |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | QCI | Class II | |
| K233734 | Interson USB Ultrasound System | Interson Corp. | IYN | Class II | |
| K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies Ltd. | GEX | Class II | |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | KCT | Class II | |
| K233205 | Distal Access Catheter | Shanghai Heartcare Medical Technology Corporation Limited | QJP | Class II | |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | ITX | Class II | |
| K233104 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd | NBW | Class II | |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd | JKA | Class II | |
| K232789 | VIO System (V-1000) | Enspectra Health, Inc. | QZN | Class II | |
| K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | LQY | Unclassified | |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K232479 | ART-Plan | Therapanacea | MUJ | Class II | |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K232300 | ElastiMed SACS | Elastimed | JOW | Class II | |
| K232293 | kallisio stentra™ oral stent | Kallisio, Inc. | IYE | Class II | |
| K231805 | qXR-LN | Qure.ai Technologies Inc | MYN | Class II | |
| K231794 | Elegant™ Advanced CompHort | Viramal Limited | NUC | Class II |