510(k) Report

Devices descending from K032858

375 later devices reach The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+4K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+4K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+4K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+4K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+4K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+4K130056Patient MonitorLd Technology, LLC20130—
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+4K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+4K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+4K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+4K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+4K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+4K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+4K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+4K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+4K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+4K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+4K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+4K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+5K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+5K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+5K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+5K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K240756Aitrics-VCAitrics Co., Ltd.20240—
+5K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+5K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+5K233216CLEWICU SystemClew Medical, Ltd.20240—
+5K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+5K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+5K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+5K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+5K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+5K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+5K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+5K212219AHI SystemFifth Eye, Inc.20211—
+5K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+5K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+5K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+5K202336Patient MonitorEdan Instruments, Inc.202131
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+5K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+5K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+5K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K160746CARDIOLINE touchECGCardioline S.P.A20160—
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+5K140430740 SelectCas Medical Systems, Inc.20141—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K121912E1 Ear SensorsMasimo Corporation20124—
+5K121424Expression Information PortalInvivo Corporation201224
+5K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+5K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+5K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K260008Deterioration Index Version 2Epic Systems Corporation20260—
+6K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K241397HinscopeHinlab Sas20240—
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+6K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+6K230842SignalHF (IM008)Implicity, Inc.20230—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—