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
+6K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201669SimpleSENSENanowear, Inc.20203—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K173510BioStamp nPointMc10, Inc.20180—
+6K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+6K163065T3 SoftwareEtiometry, Inc.201715—
+6K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+6K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+6K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+6K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+6K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K241397HinscopeHinlab Sas20240—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K230386SpassageQSpass, Inc.20231—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K223073AlioAlio, Inc.20230—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K211046eCareManager 4.5Visicu, Inc.20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K212160SimpleSENSE PlatformNanowear, Inc.20211—
+7K211305ANNE OneSibel, Inc.20216—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+7K191620Vitls PlatformVitls, Inc.20202—