510(k) Report

Devices descending from K230057

5 later devices reach Acumen Hypotension Prediction Index (HPI) Algorithm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+1K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+2K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+2K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+2K253034HemoSphere Stream ModuleEdwards Lifesciences20250—