510(k) Report

Devices descending from K061115

2 later devices reach Speedflow 0.2UM Filter, Model 11214; Speedflow 1.2UM Filter, Model 11215… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181870Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single…Wuhan W.E.O Science & Technology Development Co., Ltd.20190—
+1K080695Mobile I.V. Systems 10,20,60Northwind Technologies, Corp.20080—