510(k) Report

Devices descending from K020290

284 later devices reach Dash 3000/4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031320EK-Pro Arrhythmia Detection AlgorithmGe Medical Systems Information Technologies200342—
+1K030431Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies20032571
+2K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+2K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+2K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+2K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+2K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp2004238—
+2K033304Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies2003121
+2K031849Spectrum Patient Monitor, Model 0998-00-0500-XxxxxDatascope Corp.200391
+3K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+3K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+3K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+3K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+3K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+3K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+3K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+3K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+3K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+3K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+3K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC20062372
+3K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+3K040458Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies200401
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+4K191249Carescape B450GE Healthcare Finland Oy20204—
+4K191149Carescape B650GE Healthcare Finland Oy202072
+4K190008Carescape OneGE Healthcare201911—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K142244Cleo Patient MonitorInfinium Medical201501
+4K132229Omni Patent MonitorsInfinium Medical20142—
+4K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+4K131586Canary Breathing SystemPalo Alto Health Sciences, Inc.20132—
+4K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+4K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+4K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+4K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+5K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+5K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+5K180173FreespiraPalo Alto Health Sciences, Inc.20181—
+5K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+5K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+5K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+5K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+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
+5K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+5K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+5K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+5K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+5K112190Patient MonitorMediana Co., Ltd.20110—
+5K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+5K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+5K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+5K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+5K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+5K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+5K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+5K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+5K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+5K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+5K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+5K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+5K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+5K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+6K223498Radius VSM and AccessoriesMasimo Corporation202312
+6K222101PrismGraymatters Health, Ltd.20230—
+6K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+6K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+6K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+6K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+6K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+6K153156eCareManager 4.0.1Visicu, Inc.20163—
+6K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+6K152552Patient MonitorEdan Instruments, Inc.201621
+6K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+6K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+6K130401Alertwatch: orAlertwatch, LLC20148—
+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—