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..
FDA 510(k) Cleared Needle, Hypodermic, Single Lumen Devices (Product Code FMI)
About Product Code FMI - Regulatory Context
510(k) Submission Activity
689 total 510(k) submissions under product code FMI since 1976, with 689 receiving FDA clearance (average review time: 136 days).
Submission volume has declined in recent years - 18 submissions in the last 24 months compared to 37 in the prior period.
FDA Review Time
FDA review times for FMI submissions have been consistent, averaging 139 days recently vs 136 days historically.
FMI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →