510(k) Report

Devices descending from K031481

376 later devices reach The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+5K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+5K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+5K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+5K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+5K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+5K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+5K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+5K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+5K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+5K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+5K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+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
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+6K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+6K140430740 SelectCas Medical Systems, Inc.20141—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K121912E1 Ear SensorsMasimo Corporation20124—
+6K121424Expression Information PortalInvivo Corporation201224
+6K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+6K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+6K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+7K241397HinscopeHinlab Sas20240—
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+7K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+7K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—