OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

K222084 is the FDA 510(k) clearance record for OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie, a class II device, cleared for Asahi Polyslider Co., Ltd. on 2022-11-02 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 2 510(k) clearances for Asahi Polyslider Co., Ltd., from 2022-08-23 to 2022-11-02. As of 2026-09-10, FDA records show no recalls naming K222084.