510(k) Report

Devices descending from K213682

14 later devices reach HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+1K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+1K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+1K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+1K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+2K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+2K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+2K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+2K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+2K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+2K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+3K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+3K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+3K253034HemoSphere Stream ModuleEdwards Lifesciences20250—