510(k) Report

Devices descending from K072049

78 later devices reach Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+1K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+1K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs…Caretaker Medical, LLC201616—
+1K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+1K101123Nexfin Model 2Bmeye B.V.201054—
+1K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+2K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+2K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+2K190792BB-613WPBiobeat Technologies, Ltd.201912—
+2K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+2K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+2K124041NBM-200MPOrsense, Ltd.20131—
+2K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+3K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+3K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+3K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+3K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+3K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+4K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+4K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+4K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+4K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+4K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—
+5K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+5K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+5K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+5K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+5K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC2017412
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K212219AHI SystemFifth Eye, Inc.20211—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K221203AHI SystemFifth Eye, Inc.20220—