Carelet Safety Lancet

K931828 is the FDA 510(k) clearance record for CARELET SAFETY LANCET, a class II device, cleared for Gainor Medical Europe, Ltd. on 1993-10-15 under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "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...". FDA records list 13 510(k) clearances for Gainor Medical Europe, Ltd., from 1990-04-20 to 1994-05-02. As of 2026-09-10, FDA records show no recalls naming K931828.