510(k) Report

Devices descending from K214022

12 later devices reach Accu-Chek Softclix Blood Lancing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co.20230—
+1K230310STAT Medical Device Lancing SystemStat Medical Devices20230—
+1K222617EasyTouch Lancing DeviceStat Medical Devices20230—
+1K223815ONE DROP Lancing DeviceStat Medical Devices20230—
+1K221419TD-5010 Lancing Device and TD-5084 Sterile LancetsGostar Co., Ltd.20230—
+1K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co., Ltd.202201
+1K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health20220—
+1K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceArkray, Inc.20220—
+1K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsOwen Mumford, Ltd.20220—
+1K222034RightLance Blood Lancing SystemBeijing Ruicheng Medical Supplies Co., Ltd.20220—
+1K221546OneTouch Delica Plus Lancing SystemAsahi Polyslider Co., Ltd.20220—
+1K220608Accu-Chek FastClix Blood Lancing SystemRoche Diabetes Care, Inc.20220—