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 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..
FDA 510(k) Cleared Syringe, Piston Devices (Product Code FMF)
About Product Code FMF - Regulatory Context
510(k) Submission Activity
749 total 510(k) submissions under product code FMF since 1976, with 749 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 25 submissions in the last 24 months compared to 39 in the prior period.
FDA Review Time
Recent submissions under FMF have taken an average of 164 days to reach a decision - up from 122 days historically. Manufacturers should account for longer review timelines in current project planning.
FMF devices are reviewed by the General Hospital panel. Browse all General Hospital devices →