510(k) Report

Devices descending from K122558

4 later devices reach Ultrasafe Passive Needle Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123743Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc.20133—
+2K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.20230—
+2K141464Novaguard S a Safety SystemWest Pharmaceutical Services20141—
+3K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.20170—