510(k) Report

Devices descending from K080238

219 later devices reach Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+1K124041NBM-200MPOrsense, Ltd.20131—
+1K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc.20132—
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+1K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+1K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+1K101123Nexfin Model 2Bmeye B.V.201054—
+1K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+1K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+1K082052Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckMasimo Corporation20086—
+1K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation200841—
+2K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+2K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+2K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+2K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+2K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—
+2K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+2K140430740 SelectCas Medical Systems, Inc.20141—
+2K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+2K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+2K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+2K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+2K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+2K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+2K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+2K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+2K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation200940—
+2K091057Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation20095—
+3K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+3K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+3K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+3K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+3K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K161909IQvitals ZoneMidmark Corporation201614
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+3K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K142915ZOLL X SeriesZOLL Medical Corporation20140—
+3K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+3K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+3K133484Zoll X SeriesZoll Medical Corp20141—
+3K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+3K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+3K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+3K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+3K121367Zoll Propaq XMZOLL Medical Corporation201231
+3K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+3K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation201011
+3K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+4K213911Microstream CO2 NanoPodCovidien, LLC20220—
+4K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+4K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K180482ZOLL Propaq MZOLL Medical Corporation20182—
+4K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K170182Cardiovit FT-1Schiller AG20170—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+4K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+4K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K141774Zoll X SeriesZOLL Medical Corporation20142—
+4K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation20110—
+4K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+5K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+5K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—