510(k) Report

Devices descending from K033957

233 later devices reach Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K120173Patient MonitorEdan Instruments, Inc.201210—
+6K113653Patient MonitorEdan Instruments, Inc.201212
+6K113623Patient MonitorEdan Instruments, Inc.2012152
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+6K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K241397HinscopeHinlab Sas20240—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K211046eCareManager 4.5Visicu, Inc.20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K173715AlertWatch:OBAlertwatch, Inc.20180—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K160981Patient MonitorEdan Instruments, Inc.201681
+7K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+7K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+7K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+7K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+7K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192514Patient MonitorEdan Instruments, Inc.202061
+8K192595ExSpiron 2XiRespiratory Motion20190—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K161056Telemetry TransmitterEdan Instruments, Inc.201702
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+8K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+8K121424Expression Information PortalInvivo Corporation201224
+8K103700Essential Mri Patient MonitorInvivo Corporation20110—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—