510(k) Report

Devices descending from K011876

6 later devices reach Dolphin II Fluid Management System, Model Dol-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110852Dolphin 3 Fluid Management SystemGyrus Acmi, Inc.20110—
+1K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC201042
+2K133799Thermedx Fluid Managment SystemThermedx, LLC201432
+3K172048FluidSmartThermedx, LLC201721
+4K251273Asurys Fluid Management SystemBoston Scientific Corporation20260—
+4K210628X-FLO Fluid Management SystemThermedx, LLC20210—