510(k) Report

Devices descending from K042144

48 later devices reach NICOM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071631Nicom ElectrodesCheetah Medical, Inc.200836—
+1K072662Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc.200846—
+2K101487Cheetah Nicom SystemCheetah Medical, Inc.201035—
+2K083093Cheetah ReliantCheetah Medical, Inc.2008451
+3K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+3K122129Sphygmocor XcelAtcor Medical20126—
+3K103166Cheetah ReliantCheetah Medical, Inc.20111—
+4K221742Conneqt PulseAtcor Medical20230—
+4K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+4K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+4K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+4K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+4K151520Oscar 2Suntech Medical, Inc.201632
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+5K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+5K233216CLEWICU SystemClew Medical, Ltd.20240—
+5K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+5K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+5K212219AHI SystemFifth Eye, Inc.20211—
+5K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+5K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+5K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K260008Deterioration Index Version 2Epic Systems Corporation20260—
+6K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K230842SignalHF (IM008)Implicity, Inc.20230—
+6K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K221203AHI SystemFifth Eye, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—