510(k) Report

Devices descending from K990966

477 later devices reach Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+4K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+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
+4K093261MOVESThornhill Research, Inc.20107Class I
+4K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+4K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+4K073203Carescape V100Ge Medical Systems Information Technologies200720—
+4K060705Carina HomeDraeger Medical B.V.2006221
+4K053270IVENT 201Versamed Medical Systems, Inc.200687—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K252330DeepRESPNox Medical Ehf20250—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K180269Cadwell Apollo SystemCadwell Industries, Inc.20182—
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+5K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+5K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+5K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+5K140049Moves SLCThornhill Research, Inc.20141—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+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—
+5K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+5K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+5K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K103167Stellar 150Resmed Germany, Inc.201120—
+5K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+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—
+5K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+5K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+6K260050WRAP SystemHuneo, LLC20260—
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233438SleepStageMLBeacon Biosignals, Inc.20240—
+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—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+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—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K201819Cadwell Apollo SystemCadwell Industries, Inc.20201—
+6K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+6K182227Esprit NovaNeurozone Msh Incorporated20190—
+6K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+6K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+6K170182Cardiovit FT-1Schiller AG20170—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K161420Moves SLCThornhill Research, Inc.20170—