510(k) Report

Devices descending from K022415

17 later devices reach Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST through their predicates, nearest generation first.

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