510(k) Report

Devices descending from K021422

426 later devices reach Philips Information Center Software Revision D.02 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K171322eCareManager 4.1Visicu, Inc.20172—
+4K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K153335AlertWatch: ORAlertwatch, LLC20161—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+4K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+4K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+4K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+4K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+4K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+4K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K113853G+ SystemGlytec, LLC201212—
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+4K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+4K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+4K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+4K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+4K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+4K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+4K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+4K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K080173STAR 55Larsen & Toubro Limited20085—
+4K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+4K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+4K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+4K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+4K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+4K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+4K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+4K041815LNCS Oximetry SensorsMasimo Corp.200486—
+4K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+5K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+5K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+5K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+5K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+5K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+5K211046eCareManager 4.5Visicu, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+5K210160AlertWatch:ACAlertwatch, Inc.20210—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+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—
+5K173952Universal SmartECGVectracor, Inc.20181—
+5K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+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—
+5K152300GlucommanderGlytec, LLC20171—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K160673Insulin Algorithms SystemInsulin Algorithms20170—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+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—
+5K142918EndoTool SubQMonarch Medical Technologies20152—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies201481
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—