510(k) Report

Devices descending from K001081

117 later devices reach Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp.20049—
+1K014063Task Force Monitor 3040Cnsystems Medizintechnik GmbH20021061
+2K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+2K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+2K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+2K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+2K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp.20055—
+2K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV200381—
+2K023338Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2Fms, Finapres Medical Systems BV200381
+3K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+3K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+3K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+3K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+3K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+3K093981Yrnsortip OximanometerCnoga Medical, Ltd.20101—
+3K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.20091—
+3K072049Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Bmeye B.V.200778—
+3K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp.20074—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K190893Non-invasive Hemodynamic Blood Pressure MonitorVita-Course Technologies Co., Ltd.20190—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+4K151499CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs…Caretaker Medical, LLC201616—
+4K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+4K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K101123Nexfin Model 2Bmeye B.V.201054—
+4K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+4K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd.20090—
+5K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+5K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K124041NBM-200MPOrsense, Ltd.20131—
+5K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+6K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+7K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+7K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K223721Masimo StorkMasimo Corporation20230—
+8K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+8K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+8K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+8K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+8K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC2017412
+9K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+9K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+9K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+9K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+9K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+10K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—