FDA Product Code FMI: Needle, Hypodermic, Single Lumen
FDA product code FMI covers single-lumen hypodermic needles.
These devices consist of a hollow metallic cannula with a sharpened beveled tip designed to pierce skin and tissue for the injection of medications, aspiration of fluids, or delivery of vaccines. They are among the most widely used medical devices globally, available in a wide range of gauges and lengths.
FMI devices are Class II medical devices, regulated under 21 CFR 880.5570 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd., Becton, Dickinson and Company and Terumo Europe N.V..
List of Needle, Hypodermic, Single Lumen devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Needle, Hypodermic, Single Lumen devices (product code FMI). 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 →