510(k) Report

Devices descending from K121908

6 later devices reach Safety Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc.20182—
+1K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc.20172—
+2K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20221—
+2K211293Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20211—
+3K243806Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20250—
+3K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd.20230—