510(k) Report

Devices descending from K920429

441 later devices reach Modified Model M1403A Telemetry Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190273T3 Platform softwareEtiometry, Inc.201914—
+7K190792BB-613WPBiobeat Technologies, Ltd.201912—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+7K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K161056Telemetry TransmitterEdan Instruments, Inc.201702
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+7K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+7K121424Expression Information PortalInvivo Corporation201224
+7K103700Essential Mri Patient MonitorInvivo Corporation20110—
+8K260008Deterioration Index Version 2Epic Systems Corporation20260—
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240558NavoycdsAlgodx AB20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K223711ANNE OneSibel Health, Inc.20234—
+8K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221530ANNE PediatricSibel, Inc.20220—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K212227Philips MR Patient Care PortalInvivo Corporation202101
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K202306T3 Platform softwareEtiometry, Inc.202013—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192595ExSpiron 2XiRespiratory Motion20190—
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+8K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+8K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+9K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K243837iBSMIorbit Digital Technologies Private Limited20250—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+9K242842ANNE View, Central HubSibel Health, Inc.20251—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K240305ANNE LimbSibel Health, Inc.20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K213230T3 Platform SoftwareEtiometry, Inc.202212—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202