510(k) Report

Devices descending from K223865

7 later devices reach HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+1K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+1K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+1K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+2K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+2K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+2K253034HemoSphere Stream ModuleEdwards Lifesciences20250—