510(k) Report

Devices descending from K181221

2 later devices reach BD PhaSeal Optima Closed System Transfer Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and Company20250—
+1K201099BD PhaSeal Optima Closed System Drug Transfer DeviceBecton, Dickinson and Company202001