510(k) Report

Devices descending from K052195

13 later devices reach EZ-Mio Manual Driver through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190538NIO-IWaismed, Ltd.20191—
+1K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp.20083—
+1K063567EZ-Mio SternalVidacare Corporation20071—
+1K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation20063—
+1K062422Humeral Head, Manual DriverVidacare Corporation20060—
+2K211395NIO-IEinstein Works, LLC20210—
+2K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—
+2K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+2K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation201201
+2K100124Fastx Sternal Intraosseous DevicePyng Medical Corp.201021
+2K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation200921
+3K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation20140—
+3K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation20101—