510(k) Report

Devices descending from K882609

504 later devices reach Models M1175A & M1176A Component Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+5K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+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—
+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—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+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
+5K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+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—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K140852Vectraplex CMSVectracor, Inc.20150—
+5K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc.20142—
+5K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+5K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co.201411
+5K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+5K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201417—
+5K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131032Philips Suresigns CentralPhilips Medical Systems20131—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+5K121424Expression Information PortalInvivo Corporation201224
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K050128Vitalware VMSTelevital, Inc.20050—
+5K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200587—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K203635Patient Monitoring CablesJkh USA, LLC20212—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+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—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+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—
+6K182297Surveyor S2Mortara Instrument, Inc.20190—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K173952Universal SmartECGVectracor, Inc.20181—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—