510(k) Report

Devices descending from K970209

284 later devices reach Capnocheck Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063752Lifesense, Model LS1-9RNonin Medical, Inc.200712—
+1K030407Advisor, Model 9200Bci, Inc.2003143
+1K984033Atlas MonitorWelch Allyn, Inc.1999267—
+1K991086Capnocheck II, Model 8400Bci Intl., Inc.199901
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC20163—
+2K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102—
+2K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc.20070—
+2K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc.2002264—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K160582WiCapAthena Gtx20160—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+4K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+4K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+4K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K233827OxiWearOxiwear, Inc.20240—
+5K170820Capnograph and OximeterCmi Health, Inc.20181—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+5K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+6K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+6K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+6K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+6K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+6K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+6K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+6K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231625VitalDetectWellvii, Inc.20240—
+7K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+7K220111RespiraSensePmd Solutions20221—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+7K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—