510(k) Report

Devices descending from K040011

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+5K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+5K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+5K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+5K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+5K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K160809Reveal LINQMedtronic, Inc.201612—
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K160689Reveal LINQMedtronic, Inc.20161—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+5K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+5K140430740 SelectCas Medical Systems, Inc.20141—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+5K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+5K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+5K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+5K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+5K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+5K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+6K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+6K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+6K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+6K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+6K162855Reveal LINQMedtronic, Inc.2017111
+6K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+6K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+6K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+6K124041NBM-200MPOrsense, Ltd.20131—
+6K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+6K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+6K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+7K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+7K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K214115MightySat -OTCMasimo Corporation20241—
+7K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+7K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+7K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+7K213911Microstream CO2 NanoPodCovidien, LLC20220—
+7K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—