510(k) Report

Devices descending from K881321

12 later devices reach Blood/Solution Set W/Pressure Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Fenwal, Inc.20083—
+1K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products20057—
+2K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.20146—
+2K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc.201221
+3K170595IV Administration SetsB.Braun Medical, Inc.2017319
+3K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC20161—
+3K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.20141—
+4K213588Q2 IV Administration SetsQuest Medical, Inc.20220—
+4K202618IV Administration SetsB.Braun Medical, Inc.202101
+4K191362LifeFlow Blood System410 Medical, Inc.20200—
+4K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+4K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160—