510(k) Report

Devices descending from K915409

20 later devices reach Intraosseous Access Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation20140—
+1K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd.200217—
+1K970380F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp.19977—
+2K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation201201
+2K072487FAST1 Intraosseous Infusion SystemPyng Medical Corp.20084—
+2K063567EZ-Mio SternalVidacare Corporation20071—
+2K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation200516—
+3K190538NIO-IWaismed, Ltd.20191—
+3K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp.20083—
+3K063142Manual PD-IO; Powered PD-IOVidacare Corporation20062—
+3K052195EZ-Mio Manual DriverVidacare Corporation200513—
+3K051992Powered PD-IO Intraosseous Infusion SystemVidacare Corporation20053—
+4K211395NIO-IEinstein Works, LLC20210—
+4K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—
+4K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+4K100124Fastx Sternal Intraosseous DevicePyng Medical Corp.201021
+4K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation20101—
+4K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation20063—
+4K062422Humeral Head, Manual DriverVidacare Corporation20060—
+5K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation200921