510(k) Report

Devices descending from K032858

375 later devices reach The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K221203AHI SystemFifth Eye, Inc.20220—
+6K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K192595ExSpiron 2XiRespiratory Motion20190—
+6K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+6K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+7K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+7K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+7K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+7K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+7K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+7K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K213515WesperO2Wesper, Inc.20220—
+7K212271smart-syncNorthh Medical GmbH20220—
+7K202851Spo2 SensorJkh USA, LLC20201—
+7K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+7K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+7K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+7K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+7K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+7K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+7K173045OximeterShenzhen Greatmade Tech Limited20180—
+7K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+8K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+8K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+9K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—