510(k) Report

Devices descending from K014063

106 later devices reach Task Force Monitor 3040 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+1K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+1K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV200381—
+1K023338Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Fms, Finapres Medical Systems BV200381
+2K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+2K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+2K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+2K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+2K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+2K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+2K093981Yrnsortip OximanometerCnoga Medical, Ltd.20101—
+2K072049Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Bmeye B.V.200778—
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+3K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+3K190893Non-invasive Hemodynamic Blood Pressure MonitorVita-Course Technologies Co., Ltd.20190—
+3K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+3K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+3K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs…Caretaker Medical, LLC201616—
+3K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+3K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+3K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+3K101123Nexfin Model 2Bmeye B.V.201054—
+3K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+4K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+4K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+4K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+4K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+4K124041NBM-200MPOrsense, Ltd.20131—
+4K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+5K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+6K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+6K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K223721Masimo StorkMasimo Corporation20230—
+7K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+7K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+7K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+7K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC2017412
+8K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+8K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+8K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+9K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+9K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+9K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+10K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+10K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+10K233216CLEWICU SystemClew Medical, Ltd.20240—
+10K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+10K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+10K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+10K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+10K212219AHI SystemFifth Eye, Inc.20211—