510(k) Report

Devices descending from K981576

472 later devices reach Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+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
+5K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+5K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131032Philips Suresigns CentralPhilips Medical Systems20131—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+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
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+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—
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K050128Vitalware VMSTelevital, Inc.20050—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+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—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K203635Patient Monitoring CablesJkh USA, LLC20212—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—