510(k) Report

Devices descending from K200717

12 later devices reach CLEWICU System (ClewICUServer and ClewICUnitor) through their predicates, nearest generation first.

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