510(k) Report

Devices descending from K041415

10 later devices reach Eva TPN Container through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101412Eva TPN BagValmed S.R.L.20118—
+1K073538Dual Chamber TPN ContainerB.Braun Medical, Inc.20080—
+2K222622Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.20230—
+2K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP…Valmed S.R.L.20196—
+3K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd.20232—
+3K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC20212—
+4K251980ClaveQS™ BagIcu Medical, Inc.20260—
+4K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte., Ltd.20250—
+4K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…Technoflex Sas.20250—
+4K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd.20241—