510(k) Report

Devices descending from K200027

6 later devices reach Blood Collection Needle with/without Holder, Safety Blood Collection Needle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.20240—
+1K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+1K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company20231—
+1K213690Eclipse Blood Collection SetEclipse Medcorp, LLC20220—
+1K222141Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+2K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.20260—