510(k) Report

Devices descending from K921860

21 later devices reach Modification to IV Spike through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc.20031—
+1K023469Victus I.V. Administration Set, Models 27058, 27059,27062Victus, Inc.20022—
+1K972678Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsMcgaw, Inc.199716—
+2K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc.20100—
+2K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc.200615Class I
+2K041495Pentadeflue IV Solution Administration SetsPentaferte S.P.A20050—
+3K191910SpaceStation MRIB. Braun Melsugen AG20200Class I
+3K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.20146—
+3K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc.20141Class I
+3K121613Agilia Infusion SystemFresenius Kabi AG20132Class I
+3K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc.20094Class I
+4K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc.20250—
+4K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG20220—
+4K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…Fresenius Kabi AG20220—
+4K170595IV Administration SetsB.Braun Medical, Inc.2017319
+4K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC20161—
+4K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc.20150Class I
+5K213588Q2 IV Administration SetsQuest Medical, Inc.20220—
+5K202618IV Administration SetsB.Braun Medical, Inc.202101
+5K191362LifeFlow Blood System410 Medical, Inc.20200—
+5K191658IV Sets not made with PVCB.Braun Medical, Inc.202001