FDA Product Code FMF: Syringe, Piston
Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.
These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.
FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd., Becton, Dickinson and Company and Nipro Medical Corporation.
List of Syringe, Piston devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Syringe, Piston devices (product code FMF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →