510(k) Report

Devices descending from K010103

13 later devices reach Surshield Winged Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031266Surshield Safety Winged Infusion SetTerumo Corp.20037—
+1K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014—
+2K072894Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20073—
+2K052887Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VSTerumo Europe N.V.20056—
+2K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd.20033—
+3K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…Jiangsu Kangbao Medical Equipment Co., Ltd.20200—
+3K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection SetJiangyin Caina Technology Co., Ltd.20150—
+3K133867Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20140—
+3K100946Intravscular Administration SetTerumo Europe N.V.20102—
+3K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V.20074—
+3K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa20050—
+4K140175Intravascular Administration SetDelta Med Spa20140—
+4K133894Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V.201401