510(k) Report

Devices descending from K011297

11 later devices reach Nipro Safetouch Scalp Vein and Blood Collection Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140136Nipro Safetouch PSV Scalp Vein Set with Safety DeviceNipro Medical Corporation20140—
+1K113429Safetouch PSV Winged Infusion Set, and Set with FilterNipro Medical Corporation20121—
+1K080235Safety Infusion SetGreiner Bio-One Vacuette North America20087—
+2K132153Safetouch PSV Winged Infusion Set with/Without FilterNipro Medical Corporation20130—
+2K121908Safety Infusion SetGreiner Bio-One North America, Inc.20126—
+3K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc.20182—
+3K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc.20172—
+4K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20221—
+4K211293Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20211—
+5K243806Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20250—
+5K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd.20230—