510(k) Report

Devices descending from K072295

197 later devices reach Capnostream 20 with A2 Adaptive Averaging Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+1K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+1K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+2K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+2K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+2K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+2K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+2K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+2K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+2K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+3K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+3K220111RespiraSensePmd Solutions20221—
+3K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+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—
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+3K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+3K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+3K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K124041NBM-200MPOrsense, Ltd.20131—
+4K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+4K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+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—
+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—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+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—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+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—
+5K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+5K161909IQvitals ZoneMidmark Corporation201614
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+5K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+5K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+5K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238