510(k) Report

Devices descending from K030431

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161056Telemetry TransmitterEdan Instruments, Inc.201702
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+8K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+8K121424Expression Information PortalInvivo Corporation201224
+8K103700Essential Mri Patient MonitorInvivo Corporation20110—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K212227Philips MR Patient Care PortalInvivo Corporation202101
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202336Patient MonitorEdan Instruments, Inc.202131
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+9K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+9K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K241397HinscopeHinlab Sas20240—
+10K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+10K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+10K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+11K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+11K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+11K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+11K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+11K232915EpiMonitorEmpatica S.r.l.20241—
+11K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+11K231506Current Health SystemCurrent Health, Ltd.20230—
+12K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K252981EmbraceMiniEmpatica S.r.l.20251—
+12K250515EpiMonitorEmpatica S.r.l.20250—
+12K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+12K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—