510(k) Report

Devices descending from K040011

320 later devices reach Polaris 2004 Capnograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+1K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+1K0534623160 Mri Patient Monitoring SystemInvivo Corporation2006532
+1K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K160582WiCapAthena Gtx20160—
+2K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+2K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+2K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+2K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+2K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+2K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+2K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+2K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+3K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+3K170820Capnograph and OximeterCmi Health, Inc.20181—
+3K143503BioMonitorBiotronik, Inc.20159—
+3K132960BiomonitorBiotronik, Inc.201410—
+3K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+3K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+3K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+3K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+3K122161SJM ConfirmSt Jude Medical20124—
+3K121424Expression Information PortalInvivo Corporation201224
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+3K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+3K103700Essential Mri Patient MonitorInvivo Corporation20110—
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+3K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+3K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+3K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+3K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+3K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+3K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+3K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+4K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K212227Philips MR Patient Care PortalInvivo Corporation202101
+4K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+4K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+4K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+4K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+4K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K150614Reveal LINQMedtronic, Inc.201515—
+4K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+4K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+4K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+4K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+4K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K231625VitalDetectWellvii, Inc.20240—
+5K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+5K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+5K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+5K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K220111RespiraSensePmd Solutions20221—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K212271smart-syncNorthh Medical GmbH20220—
+5K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+5K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—