510(k) Report

Devices descending from K844187

253 later devices reach Siemens Sirecust 404N Neonatal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+12K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+12K212219AHI SystemFifth Eye, Inc.20211—
+12K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+12K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+12K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+12K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+12K192514Patient MonitorEdan Instruments, Inc.202061
+12K192595ExSpiron 2XiRespiratory Motion20190—
+12K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+12K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+12K161056Telemetry TransmitterEdan Instruments, Inc.201702
+12K160746CARDIOLINE touchECGCardioline S.P.A20160—
+12K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+12K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+12K121424Expression Information PortalInvivo Corporation201224
+12K103700Essential Mri Patient MonitorInvivo Corporation20110—
+13K260008Deterioration Index Version 2Epic Systems Corporation20260—
+13K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+13K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+13K252981EmbraceMiniEmpatica S.r.l.20251—
+13K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+13K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+13K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+13K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+13K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+13K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+13K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+13K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+13K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+13K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+13K230842SignalHF (IM008)Implicity, Inc.20230—
+13K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+13K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+13K221203AHI SystemFifth Eye, Inc.20220—
+13K212227Philips MR Patient Care PortalInvivo Corporation202101
+13K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+13K202336Patient MonitorEdan Instruments, Inc.202131
+13K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+13K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+13K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+14K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+14K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+14K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+14K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+14K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+14K212271smart-syncNorthh Medical GmbH20220—
+15K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+15K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—