510(k) Report

Devices descending from K040259

312 later devices reach Masimo Set Intellivue Pulse Oximeter Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+6K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+6K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+6K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+6K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K231506Current Health SystemCurrent Health, Ltd.20230—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K202851Spo2 SensorJkh USA, LLC20201—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+6K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+6K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+6K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+6K173045OximeterShenzhen Greatmade Tech Limited20180—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+6K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+6K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K121424Expression Information PortalInvivo Corporation201224
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+7K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+7K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+7K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+7K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—