FMK

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product code

FMK

Device name

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Device class

Class 2

21 CFR

21 CFR 878.4850

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

110

FDA classification definition

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (20)

Last three years. Most recent: 2026-05-01.

20 summaries are archived here for direct download.