510(k) Report

Devices descending from K211206

2 later devices reach FreedomEdge (R) Syringe Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems20221—
+2K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.20260—