510(k) Report

Devices descending from K080865

3 later devices reach FAST1 Intraosseous Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—
+1K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+1K100124Fastx Sternal Intraosseous DevicePyng Medical Corp.201021