510(k) Report

Devices descending from K020290

284 later devices reach Dash 3000/4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+9K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+9K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+9K240756Aitrics-VCAitrics Co., Ltd.20240—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+9K233216CLEWICU SystemClew Medical, Ltd.20240—
+9K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+9K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+9K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+9K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K192514Patient MonitorEdan Instruments, Inc.202061
+9K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+9K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+9K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+9K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+9K161056Telemetry TransmitterEdan Instruments, Inc.201702
+9K160746CARDIOLINE touchECGCardioline S.P.A20160—
+9K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+9K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+9K121424Expression Information PortalInvivo Corporation201224
+9K103700Essential Mri Patient MonitorInvivo Corporation20110—
+10K260008Deterioration Index Version 2Epic Systems Corporation20260—
+10K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+10K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+10K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+10K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+10K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+10K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+10K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+10K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+10K221203AHI SystemFifth Eye, Inc.20220—
+10K212227Philips MR Patient Care PortalInvivo Corporation202101
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K202336Patient MonitorEdan Instruments, Inc.202131
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+10K192595ExSpiron 2XiRespiratory Motion20190—
+10K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+10K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+10K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+11K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+11K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+11K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+11K241397HinscopeHinlab Sas20240—
+11K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+11K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+11K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+11K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+11K222550Current Health SystemCurrent Health, Ltd.20221—
+11K212271smart-syncNorthh Medical GmbH20220—
+11K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+11K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+12K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+12K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+12K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+12K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+12K232915EpiMonitorEmpatica S.r.l.20241—
+12K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+13K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K252981EmbraceMiniEmpatica S.r.l.20251—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+13K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—