510(k) Report

Devices descending from K183646

15 later devices reach Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+1K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+1K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+2K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+2K233216CLEWICU SystemClew Medical, Ltd.20240—
+2K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+2K212219AHI SystemFifth Eye, Inc.20211—
+3K260008Deterioration Index Version 2Epic Systems Corporation20260—
+3K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+3K221203AHI SystemFifth Eye, Inc.20220—
+4K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—