510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+5K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+5K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+5K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+5K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+5K181352Loop SystemSpry Health, Inc.201910—
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K173510BioStamp nPointMc10, Inc.20180—
+5K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+5K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+5K172890SedLine Sedation MonitorMasimo Corporation20185—
+5K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+5K170497V10Mediana Co., Ltd.201711
+5K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+5K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+5K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+5K140502Zoll E Series AlsZOLL Medical Corporation20141—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+5K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+5K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+5K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+5K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+5K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+5K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+5K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—
+5K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+5K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+5K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+5K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+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
+5K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+5K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+5K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+5K081574Zoll R SeriesZOLL Medical Corporation20088—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+5K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K253274BedDot (G1)Intelligent Dots, LLC20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—