510(k) Report

Devices descending from K883014

8 later devices reach Modified Intended Use of Monoject Bone Marrow Need through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp.20083—
+4K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—
+4K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+4K100124Fastx Sternal Intraosseous DevicePyng Medical Corp.201021