510(k) Report

Devices descending from K230919

3 later devices reach Acumen IQ finger cuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+2K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+2K253034HemoSphere Stream ModuleEdwards Lifesciences20250—