510(k) Report

Devices descending from K140131

8 later devices reach Sub-Q Subcutaneous Tissue Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201626Safety Subcutaneous Infusion SetEpic Medical Pte., Ltd.20210—
+1K142319SCIg60 Infuser, InfusetEmed Technologies Corporation20156—
+2K161906SCIg60 InfuserEmed Technologies Corporation20165—
+3K222087SCIg60 Infusion SystemEmed Technologies Corporation20223—
+3K173783SCIg60 Infusion SystemEmed Technologies Corporation20180—
+4K240148SCIg60 Infusion SystemEmed Technologies Corporation20241—
+4K230883VersaPump Infusion SystemEmed Technologies Corporation20230—
+5K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation20250—