510(k) Report

Devices descending from K040917

252 later devices reach Philips Anesthesia Gas Monitor, Model M1026B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+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
+5K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+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—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+5K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+5K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+5K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…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—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—
+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
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+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—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+7K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+7K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+7K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341