510(k) Report

Devices descending from K081793

143 later devices reach Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+5K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+5K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+5K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+5K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+5K202336Patient MonitorEdan Instruments, Inc.202131
+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—
+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—
+5K160746CARDIOLINE touchECGCardioline S.P.A20160—
+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—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+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—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+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—