510(k) Report

Devices descending from K844187

253 later devices reach Siemens Sirecust 404N Neonatal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+10K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+10K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+10K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+10K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+10K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+10K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+10K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+10K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+10K172226MX40 Release B.07Philips Medical Systems201713—
+10K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+10K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+10K171322eCareManager 4.1Visicu, Inc.20172—
+10K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+10K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+10K153335AlertWatch: ORAlertwatch, LLC20161—
+10K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+10K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+10K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+10K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+10K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+10K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+10K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+10K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+10K120173Patient MonitorEdan Instruments, Inc.201210—
+10K113653Patient MonitorEdan Instruments, Inc.201212
+10K113623Patient MonitorEdan Instruments, Inc.2012152
+10K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+10K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+10K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+10K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+11K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+11K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+11K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+11K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+11K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+11K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+11K241397HinscopeHinlab Sas20240—
+11K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+11K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+11K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+11K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+11K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+11K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+11K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+11K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+11K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+11K222550Current Health SystemCurrent Health, Ltd.20221—
+11K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+11K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+11K211046eCareManager 4.5Visicu, Inc.20220—
+11K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+11K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+11K210160AlertWatch:ACAlertwatch, Inc.20210—
+11K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+11K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+11K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+11K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+11K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+11K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+11K180017MX40 Release C.01Philips Medical Systems20181—
+11K173715AlertWatch:OBAlertwatch, Inc.20180—
+11K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+11K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+11K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+11K160981Patient MonitorEdan Instruments, Inc.201681
+11K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+11K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+11K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+11K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+11K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+11K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+11K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+12K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+12K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+12K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+12K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+12K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+12K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+12K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+12K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+12K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+12K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+12K240756Aitrics-VCAitrics Co., Ltd.20240—
+12K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+12K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+12K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+12K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+12K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+12K232915EpiMonitorEmpatica S.r.l.20241—
+12K233216CLEWICU SystemClew Medical, Ltd.20240—
+12K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+12K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+12K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+12K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+12K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+12K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+12K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+12K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—