510(k) Report

Devices descending from K011369

6 later devices reach Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123743Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc.20133—
+1K122558Ultrasafe Passive Needle GuardSafety Syringes, Inc.20124—
+1K042712Tamper Evident Ultrasafe Passive Delivery SystemSafety Syringes, Inc.20040—
+2K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.20230—
+2K141464Novaguard S a Safety SystemWest Pharmaceutical Services20141—
+3K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.20170—