510(k) Report

Devices descending from K130468

5 later devices reach Orbit Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150921Orbit Infusion SetYpsomed AG20160—
+1K150059BD FlowSmart SetBecton, Dickinson Company20153—
+2K153257BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company20152—
+3K160651BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company201612
+4K181718BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company20180—