FDA Product Code FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Single-use lancets with integrated sharps protection represent a significant advance in patient and healthcare worker safety. FDA product code FMK covers disposable blood lancets with integral sharps protection for single use.
These devices have a retractable or permanently shielded blade that is exposed only during the lancing action, preventing needle-stick injuries after use. They are used for capillary blood sampling in glucose monitoring and other point-of-care tests.
FMK devices are Class II medical devices, regulated under 21 CFR 878.4850 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Promisemed Hangzhou Meditech Co., Ltd. and Becton, Dickinson and Company.
List of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature devices (product code FMK). 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 & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →