510(k) Report

Devices descending from K873435

9 later devices reach Level 1 IR-600 Normothermic Irrigating Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc.20087Class I
+1K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc.200681
+2K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical20260—
+2K172048FluidSmartThermedx, LLC201721
+2K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160—
+2K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC201042
+3K251273Asurys Fluid Management SystemBoston Scientific Corporation20260—
+3K210628X-FLO Fluid Management SystemThermedx, LLC20210—
+3K133799Thermedx Fluid Managment SystemThermedx, LLC201432