510(k) Report

Devices descending from K100124

2 later devices reach Fastx Sternal Intraosseous Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+2K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—