510(k) Report

Devices descending from K962603

1,002 later devices reach Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+7K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+7K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+7K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+7K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+7K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+7K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+7K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+7K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+7K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+7K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+7K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+7K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+7K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+7K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+7K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+7K061627Modification to I Vent 201Versamed Medical Systems, Inc.200686—
+7K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+8K260050WRAP SystemHuneo, LLC20260—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+8K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+8K243765LuMon (TM) SystemSentec AG20250—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K233827OxiWearOxiwear, Inc.20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K233438SleepStageMLBeacon Biosignals, Inc.20240—
+8K231625VitalDetectWellvii, Inc.20240—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K223721Masimo StorkMasimo Corporation20230—
+8K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+8K230386SpassageQSpass, Inc.20231—
+8K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+8K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+8K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+8K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+8K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+8K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+8K220111RespiraSensePmd Solutions20221—
+8K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+8K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+8K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+8K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+8K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+8K201819Cadwell Apollo SystemCadwell Industries, Inc.20201—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+8K192514Patient MonitorEdan Instruments, Inc.202061
+8K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+8K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+8K190273T3 Platform softwareEtiometry, Inc.201914—
+8K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+8K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+8K190792BB-613WPBiobeat Technologies, Ltd.201912—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+8K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+8K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K180779Savina 300Dragerwerk AG & CO Kgaa20190—
+8K182227Esprit NovaNeurozone Msh Incorporated20190—
+8K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+8K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+8K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+8K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+8K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+8K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+8K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+8K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+8K173510BioStamp nPointMc10, Inc.20180—
+8K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+8K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+8K172890SedLine Sedation MonitorMasimo Corporation20185—
+8K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+8K170497V10Mediana Co., Ltd.201711
+8K172226MX40 Release B.07Philips Medical Systems201713—
+8K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+8K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+8K163664Health-e-Connect System with IDAAlr Technologies20170—