510(k) Report

Devices descending from K201936

2 later devices reach SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251980ClaveQS™ BagIcu Medical, Inc.20260—
+1K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…Technoflex Sas.20250—