510(k) Report

Devices descending from K052801

234 later devices reach Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+4K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+4K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+4K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+4K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+4K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+4K211046eCareManager 4.5Visicu, Inc.20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+4K210160AlertWatch:ACAlertwatch, Inc.20210—
+4K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+4K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+4K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+4K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+4K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K173715AlertWatch:OBAlertwatch, Inc.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K131032Philips Suresigns CentralPhilips Medical Systems20131—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+4K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+5K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+5K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+5K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+5K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+5K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K240756Aitrics-VCAitrics Co., Ltd.20240—
+5K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+5K233216CLEWICU SystemClew Medical, Ltd.20240—
+5K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+5K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+5K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+5K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+5K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+5K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+5K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+5K212219AHI SystemFifth Eye, Inc.20211—
+5K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+5K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+5K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+5K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K160746CARDIOLINE touchECGCardioline S.P.A20160—
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K121424Expression Information PortalInvivo Corporation201224
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K260008Deterioration Index Version 2Epic Systems Corporation20260—
+6K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+6K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+6K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+6K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+6K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+6K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+6K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+6K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+6K230842SignalHF (IM008)Implicity, Inc.20230—
+6K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K221203AHI SystemFifth Eye, Inc.20220—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202336Patient MonitorEdan Instruments, Inc.202131