510(k) Report

Devices descending from K051608

259 later devices reach Star 50 Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080173STAR 55Larsen & Toubro Limited20085—
+1K071472Planet 55Larsen & Toubro Limited20071—
+1K061816GalaxyLarsen & Toubro Limited20060—
+1K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+2K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+2K160582WiCapAthena Gtx20160—
+2K103686STAR 50 NLarsen & Toubro Limited20111—
+2K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+2K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+2K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+2K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+2K090172Star 55 Model 100Larsen & Toubro Limited20090—
+2K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K082685Galaxy 55Larsen & Toubro Limited20080—
+2K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+3K170820Capnograph and OximeterCmi Health, Inc.20181—
+3K132033BM3/BM3 PlusNoblitt & Rueland20130—
+3K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K110922Patient MonitorEdan Instruments, Inc.201111
+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—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+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—
+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—
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.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
+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—
+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—
+5K231625VitalDetectWellvii, Inc.20240—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K220111RespiraSensePmd Solutions20221—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K170182Cardiovit FT-1Schiller AG20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K152552Patient MonitorEdan Instruments, Inc.201621
+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—
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+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—
+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—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—