510(k) Report

Devices descending from K030038

404 later devices reach Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+3K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+3K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+3K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+3K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+3K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+3K172226MX40 Release B.07Philips Medical Systems201713—
+3K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+3K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+3K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+3K171322eCareManager 4.1Visicu, Inc.20172—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+3K153335AlertWatch: ORAlertwatch, LLC20161—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+3K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+3K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+3K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+3K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+3K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+3K131032Philips Suresigns CentralPhilips Medical Systems20131—
+3K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+3K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+3K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+3K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+3K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+3K103686STAR 50 NLarsen & Toubro Limited20111—
+3K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+3K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+3K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+3K090172Star 55 Model 100Larsen & Toubro Limited20090—
+3K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+3K082685Galaxy 55Larsen & Toubro Limited20080—
+3K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+3K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+3K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+3K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+3K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+3K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+3K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+3K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+3K050128Vitalware VMSTelevital, Inc.20050—
+3K041815LNCS Oximetry SensorsMasimo Corp.200486—
+4K253436c-med0 alphaCosinuss GmbH20260—
+4K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+4K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+4K231625VitalDetectWellvii, Inc.20240—
+4K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+4K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+4K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+4K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+4K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+4K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+4K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+4K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+4K211046eCareManager 4.5Visicu, Inc.20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+4K210160AlertWatch:ACAlertwatch, Inc.20210—
+4K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+4K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+4K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+4K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+4K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+4K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K173952Universal SmartECGVectracor, Inc.20181—
+4K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K173715AlertWatch:OBAlertwatch, Inc.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+4K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+4K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K132033BM3/BM3 PlusNoblitt & Rueland20130—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—