510(k) Report

Devices descending from K231248

6 later devices reach Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+1K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+2K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+2K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+3K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+3K253034HemoSphere Stream ModuleEdwards Lifesciences20250—