510(k) Report

Devices descending from K903523

463 later devices reach HP Model M1020A, Arterial Oxygen Sat/Pleth Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+6K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K153335AlertWatch: ORAlertwatch, LLC20161—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+6K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+6K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+6K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+6K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+6K121424Expression Information PortalInvivo Corporation201224
+6K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+6K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+6K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+6K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+6K080173STAR 55Larsen & Toubro Limited20085—
+6K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+6K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+6K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+6K050128Vitalware VMSTelevital, Inc.20050—
+6K041815LNCS Oximetry SensorsMasimo Corp.200486—
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+7K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+7K211046eCareManager 4.5Visicu, Inc.20220—
+7K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+7K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K203635Patient Monitoring CablesJkh USA, LLC20212—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+7K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+7K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+7K173952Universal SmartECGVectracor, Inc.20181—
+7K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+7K173715AlertWatch:OBAlertwatch, Inc.20180—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+7K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+7K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661