510(k) Report

Devices descending from K021251

262 later devices reach ST/AR ST and Arrhythmia Software, Release E.I. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+1K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+1K070260Star ST and Arrhythmia Software, Release H.0Philips Medical Systems20077—
+1K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Philips Medical Systems, Inc.2004260—
+2K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+2K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+2K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+2K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+2K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+2K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+2K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+2K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+2K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+2K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+2K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+2K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+2K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+2K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+2K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+2K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+2K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+2K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+2K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+2K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+2K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+2K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+2K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+2K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+2K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+2K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005250—
+2K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251—
+2K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+2K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252—
+2K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410—
+3K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+3K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+3K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+3K172226MX40 Release B.07Philips Medical Systems201713—
+3K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+3K152552Patient MonitorEdan Instruments, Inc.201621
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+3K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+3K130401Alertwatch: orAlertwatch, LLC20148—
+3K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+3K131032Philips Suresigns CentralPhilips Medical Systems20131—
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+3K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+3K120087ExspironRespiratory Motion, Inc.20128—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+3K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+3K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+3K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+3K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+3K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+3K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+3K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+3K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+3K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+3K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+3K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+3K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+3K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+3K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+3K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+3K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+3K050128Vitalware VMSTelevital, Inc.20050—
+4K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+4K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+4K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K220111RespiraSensePmd Solutions20221—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+4K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+4K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+4K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+4K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+4K153335AlertWatch: ORAlertwatch, LLC20161—