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 Tianjin Huahong Technology Co., Ltd., Ningbo Medsun Medical Co., Ltd. and Promisemed Hangzhou Meditech Co., Ltd..
FDA 510(k) Cleared Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Devices (Product Code FMK)
About Product Code FMK - Regulatory Context
510(k) Submission Activity
109 total 510(k) submissions under product code FMK since 1981, with 109 receiving FDA clearance (average review time: 91 days).
Submission volume has declined in recent years - 14 submissions in the last 24 months compared to 37 in the prior period.
FDA Review Time
Recent submissions under FMK have taken an average of 65 days to reach a decision - down from 96 days historically, suggesting improved FDA processing for this classification.
FMK devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →