510(k) Report

Devices descending from K161906

5 later devices reach SCIg60 Infuser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222087SCIg60 Infusion SystemEmed Technologies Corporation20223—
+1K173783SCIg60 Infusion SystemEmed Technologies Corporation20180—
+2K240148SCIg60 Infusion SystemEmed Technologies Corporation20241—
+2K230883VersaPump Infusion SystemEmed Technologies Corporation20230—
+3K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation20250—