510(k) Report

Devices descending from K101109

12 later devices reach Vivatrak through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131585Intel-GE Care Innovations QuietcareIntel-Ge Care Innovations, LLC20130—
+1K130752Dynasense SystemCentauri Medical, Inc.20136—
+1K103536Ibed Wireless with Ibed AwarenessStryker Corporation20103—
+2K202964iBed Wireless with iBed MobileStryker Corporation20210—
+2K143414Hill-Rom Wireless Connectivity ModuleHill-Rom20150—
+2K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc.20145—
+2K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom201302
+3K233096PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC20240—
+3K191882Masimo Centroid SystemMasimo Corporation20203—
+4K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+4K223498Radius VSM and AccessoriesMasimo Corporation202312
+5K250757Radius VSM and AccessoriesMasimo Corporation20250—