510(k) Report

Devices descending from K162613

6 later devices reach Integrated Catch-up Freedom Syringe Driver Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200176FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc. Dba Koru Medical Systems20212—
+1K211206FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems20212—
+2K232328Insignis™ Syringe Infusion SystemInnovative Health Sciences, LLC20240—
+2K231918Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing…Koru Medical Systems20230—
+2K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems20221—
+3K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.20260—