510(k) Report

Devices descending from K944350

248 later devices reach SC 6000/ SC 6000P/ R50 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+10K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+10K192514Patient MonitorEdan Instruments, Inc.202061
+10K192595ExSpiron 2XiRespiratory Motion20190—
+10K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+10K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+10K161056Telemetry TransmitterEdan Instruments, Inc.201702
+10K160746CARDIOLINE touchECGCardioline S.P.A20160—
+10K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+10K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+10K121424Expression Information PortalInvivo Corporation201224
+10K103700Essential Mri Patient MonitorInvivo Corporation20110—
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+11K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+11K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+11K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+11K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+11K230842SignalHF (IM008)Implicity, Inc.20230—
+11K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+11K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+11K221203AHI SystemFifth Eye, Inc.20220—
+11K212227Philips MR Patient Care PortalInvivo Corporation202101
+11K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+11K202336Patient MonitorEdan Instruments, Inc.202131
+11K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+11K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+11K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+12K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+12K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+12K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+12K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+12K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+12K212271smart-syncNorthh Medical GmbH20220—
+13K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+13K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—