510(k) Report

Devices descending from K853990

246 later devices reach OSM3 Hemoximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation20082191
+1K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation2006226—
+1K050014Hemonir TMNir Diagnostics, Inc.20050—
+1K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation20052441
+2K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+2K124041NBM-200MPOrsense, Ltd.20131—
+2K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc.20132—
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+2K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+2K101123Nexfin Model 2Bmeye B.V.201054—
+2K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+2K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+2K082052Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckMasimo Corporation20086—
+2K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation200841—
+2K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation2006225—
+2K051439Lnop Blue Oximetry SensorMasimo Corporation200539—
+3K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+3K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc.20161—
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+3K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—
+3K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+3K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+3K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+3K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+3K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+3K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+3K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation200940—
+3K091057Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation20095—
+3K063140Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200644—
+3K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+4K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+4K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+4K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc.20180—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K142915ZOLL X SeriesZOLL Medical Corporation20140—
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+4K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+4K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation201011
+4K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+4K071024Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200743—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+5K213911Microstream CO2 NanoPodCovidien, LLC20220—
+5K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+5K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K172890SedLine Sedation MonitorMasimo Corporation20185—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+5K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I