510(k) Report

Devices descending from K013427

407 later devices reach Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K211046eCareManager 4.5Visicu, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+5K210160AlertWatch:ACAlertwatch, Inc.20210—
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+5K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+5K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+5K131032Philips Suresigns CentralPhilips Medical Systems20131—
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K103686STAR 50 NLarsen & Toubro Limited20111—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K090172Star 55 Model 100Larsen & Toubro Limited20090—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082685Galaxy 55Larsen & Toubro Limited20080—
+5K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+5K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K050128Vitalware VMSTelevital, Inc.20050—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K231625VitalDetectWellvii, Inc.20240—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+6K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K173952Universal SmartECGVectracor, Inc.20181—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—