510(k) Report

Devices descending from K063725

175 later devices reach MP5 Intellivue Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+4K210160AlertWatch:ACAlertwatch, Inc.20210—
+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
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+4K173715AlertWatch:OBAlertwatch, Inc.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+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—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+4K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K121424Expression Information PortalInvivo Corporation201224
+4K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+5K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+5K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+5K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+5K240756Aitrics-VCAitrics Co., Ltd.20240—
+5K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+5K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+5K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K212227Philips MR Patient Care PortalInvivo Corporation202101
+5K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+5K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+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—
+5K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+5K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+6K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K241397HinscopeHinlab Sas20240—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212271smart-syncNorthh Medical GmbH20220—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.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—