TD-5010 Lancing Device and TD-5084 Sterile Lancets

K221419 is the FDA 510(k) clearance record for TD-5010 Lancing Device and TD-5084 Sterile Lancets, a class II device, cleared for Gostar Co., Ltd. on 2023-01-20 under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only). FDA's definition for product code QRL reads: "A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". FDA records list 3 510(k) clearances for Gostar Co., Ltd., from 2023-01-20 to 2024-11-20. As of 2026-09-10, FDA records show no recalls naming K221419.