510(k) Report

Devices descending from K000126

560 later devices reach Masimo Set Radical Pulse Oximeter with Satshare, Masimo… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+6K173045OximeterShenzhen Greatmade Tech Limited20180—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+6K170182Cardiovit FT-1Schiller AG20170—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+6K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+6K153335AlertWatch: ORAlertwatch, LLC20161—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K150268CerOXOr-Nim Medical, Ltd.20150—
+6K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+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
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+6K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+6K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+6K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+6K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+6K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+6K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+6K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation200940—
+6K091057Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation20095—
+6K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+6K073024Masimo Rainbow Set Rad 87 Pulse CO-Oximeter and AccessoriesMasimo Corporation20080—
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K253274BedDot (G1)Intelligent Dots, LLC20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+7K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+7K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K241397HinscopeHinlab Sas20240—
+7K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+7K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+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—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+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
+7K212271smart-syncNorthh Medical GmbH20220—
+7K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+7K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+7K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+7K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+7K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+7K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+7K173715AlertWatch:OBAlertwatch, Inc.20180—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K162832731 Series VentilatorsZOLL Medical Corporation20171Class I