510(k) Report

Devices descending from K181393

6 later devices reach Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd.20232—
+1K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC20212—
+2K251980ClaveQS™ BagIcu Medical, Inc.20260—
+2K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte., Ltd.20250—
+2K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…Technoflex Sas.20250—
+2K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd.20241—