510(k) Report

Devices descending from K033296

279 later devices reach Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+5K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+5K122438Hamilton-MR1Hamilton Medical AG201311
+5K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+5K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+5K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+5K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+5K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation200940—
+5K091057Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation20095—
+5K071024Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200743—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231506Current Health SystemCurrent Health, Ltd.20230—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K220111RespiraSensePmd Solutions20221—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+6K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+6K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+6K161909IQvitals ZoneMidmark Corporation201614
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+6K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC2014521
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation201011
+6K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+6K073024Masimo Rainbow Set Rad 87 Pulse CO-Oximeter and AccessoriesMasimo Corporation20080—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+7K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+7K213911Microstream CO2 NanoPodCovidien, LLC20220—
+7K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K190130The ClearSight finger cuffsEdwards Lifesciences, LLC201929—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC201830—
+7K172890SedLine Sedation MonitorMasimo Corporation20185—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC201651Class I
+7K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+7K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation20110—
+7K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+8K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+8K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271