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
+7K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+7K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+7K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+7K161056Telemetry TransmitterEdan Instruments, Inc.201702
+7K161909IQvitals ZoneMidmark Corporation201614
+7K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+7K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+7K133484Zoll X SeriesZoll Medical Corp20141—
+7K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+7K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+7K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+7K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+7K131032Philips Suresigns CentralPhilips Medical Systems20131—
+7K121367Zoll Propaq XMZOLL Medical Corporation201231
+7K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation201011
+8K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+8K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K233486731 Series VentilatorZOLL Medical Corporation20240—
+8K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+8K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+8K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+8K180482ZOLL Propaq MZOLL Medical Corporation20182—
+8K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+8K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+8K172890SedLine Sedation MonitorMasimo Corporation20185—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K153046Hamilton-MR1Hamilton Medical AG20160Class I
+8K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+8K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+8K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+8K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+8K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+8K141774Zoll X SeriesZOLL Medical Corporation20142—
+8K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation20110—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K230842SignalHF (IM008)Implicity, Inc.20230—