510(k) Report

Devices descending from K170386

3 later devices reach BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190054BD Insulin SyringeBecton, Dickinson and Company201928
+2K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC20260—
+2K212499BD Insulin Syringe (0.3mL)Becton, Dickinson and Company20220—