510(k) Report

Devices descending from K022889

289 later devices reach Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K241397HinscopeHinlab Sas20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192595ExSpiron 2XiRespiratory Motion20190—
+8K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+8K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+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—
+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—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+9K212227Philips MR Patient Care PortalInvivo Corporation202101
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+9K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+9K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—