510(k) Report

Devices descending from K001020

270 later devices reach 8100 Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+1K051608Star 50 Monitoring SystemLarsen & Toubro Limited2005259—
+1K043370Planet 50 Monitoring SystemLarsen & Toubro Limited20052—
+1K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited2003260—
+1K032871Planet Monitoring SystemLarsen & Toubro Limited20038—
+2K080173STAR 55Larsen & Toubro Limited20085—
+2K071472Planet 55Larsen & Toubro Limited20071—
+2K061816GalaxyLarsen & Toubro Limited20060—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+2K060058Stellar 404TLarsen & Toubro Limited20066—
+2K042560Stellar 404 Monitoring SystemLarsen & Toubro Limited20047—
+3K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+3K160582WiCapAthena Gtx20160—
+3K103686STAR 50 NLarsen & Toubro Limited20111—
+3K103763Stellar 300Larsen & Toubro Limited20112—
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K093017Stellar 300Larsen & Toubro Limited20102—
+3K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+3K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+3K090443Planet 55, Model 100Larsen & Toubro Limited20090—
+3K090172Star 55 Model 100Larsen & Toubro Limited20090—
+3K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+3K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+3K082685Galaxy 55Larsen & Toubro Limited20080—
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K170820Capnograph and OximeterCmi Health, Inc.20181—
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K132033BM3/BM3 PlusNoblitt & Rueland20130—
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+4K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+4K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+4K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+5K150620740 SelectCas Medical Systems, Inc.201501
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+5K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+5K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K231625VitalDetectWellvii, Inc.20240—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K220111RespiraSensePmd Solutions20221—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+6K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+6K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K170182Cardiovit FT-1Schiller AG20170—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K152552Patient MonitorEdan Instruments, Inc.201621
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K140430740 SelectCas Medical Systems, Inc.20141—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+6K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+6K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352