510(k) Report

Devices descending from K072080

7 later devices reach Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical20260—
+1K172048FluidSmartThermedx, LLC201721
+1K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160—
+1K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC201042
+2K251273Asurys Fluid Management SystemBoston Scientific Corporation20260—
+2K210628X-FLO Fluid Management SystemThermedx, LLC20210—
+2K133799Thermedx Fluid Managment SystemThermedx, LLC201432