510(k) Report

Devices descending from K222087

3 later devices reach SCIg60 Infusion System through their predicates, nearest generation first.

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