510(k) Report

Devices descending from K082268

170 later devices reach CAPNOSTREAM20 with Integrated Pulmonary Index through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+1K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+1K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+2K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+2K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+2K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+2K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+2K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+2K140430740 SelectCas Medical Systems, Inc.20141—
+2K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+2K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+2K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+2K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+2K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+3K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+3K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+3K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+3K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+3K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K133484Zoll X SeriesZoll Medical Corp20141—
+3K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+3K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+3K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+3K124041NBM-200MPOrsense, Ltd.20131—
+3K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+3K121367Zoll Propaq XMZOLL Medical Corporation201231
+3K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+3K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+4K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K180482ZOLL Propaq MZOLL Medical Corporation20182—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+4K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+4K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+4K142915ZOLL X SeriesZOLL Medical Corporation20140—
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K141774Zoll X SeriesZOLL Medical Corporation20142—
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+4K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+4K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K213911Microstream CO2 NanoPodCovidien, LLC20220—
+5K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+5K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K202375ZOLL Propaq MZOLL Medical Corporation20211—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+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—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+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—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+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—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—