510(k) Report

Devices descending from K012770

292 later devices reach Infinity MICRO2+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+8K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+8K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+9K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+9K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+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—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K241397HinscopeHinlab Sas20240—
+9K240756Aitrics-VCAitrics Co., Ltd.20240—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+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—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+9K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+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
+9K202336Patient MonitorEdan Instruments, Inc.202131
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+9K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+9K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+9K160746CARDIOLINE touchECGCardioline S.P.A20160—
+9K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+9K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+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—
+10K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+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—
+10K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+10K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K221203AHI SystemFifth Eye, Inc.20220—
+10K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+10K212227Philips MR Patient Care PortalInvivo Corporation202101
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+10K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+10K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+11K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K212271smart-syncNorthh Medical GmbH20220—
+11K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+11K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—