510(k) Report

Devices descending from K883955

9 later devices reach Single-Fil (TM) Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0429341BD Soloshot IX SyringeBecton, Dickinson & CO20048—
+2K201234BD SoloShot Mini Syringe/ BD Auto Disable SyringeBecton, Dickinson and Company20205—
+2K091377BD Flu+ SyringeBecton, Dickinson & CO20091—
+3K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd.20221—
+3K210464Auto Disable SyringeAnhui Tiankang Medical Technology Co., Ltd.20212—
+3K203359BD Flu+ SyringeBecton, Dickinson and Company20210—
+4K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+4K234024HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20240—
+4K231519Revital CadyRevital Healthcare (Epz) Limited20230—