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
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+6K162627EnsoSleepEnsodata, Inc.20179—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K152659V10Mediana Co., Ltd.20162—
+6K152552Patient MonitorEdan Instruments, Inc.201621
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+6K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+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—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+6K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+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
+6K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K121225Hamilton-C2Hamilton Medical AG20128Class I
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K113288Vpap ST-aResmed, Ltd.20127—
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K112914Vpap TXResmed, Ltd.20110—
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+6K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+6K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+6K081845IVENT101Versamed Medical Systems, Inc.20090—
+6K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+7K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K214115MightySat -OTCMasimo Corporation20241—
+7K221959Q21Neurofield, Inc.20230—
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K221179SomnoMetryNeumetry Medical, Inc.20223—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K213911Microstream CO2 NanoPodCovidien, LLC20220—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse 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—
+7K210034EnsoSleepEnsodata, Inc.20210—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+7K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+7K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K170497V10Mediana Co., Ltd.201711
+7K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+7K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+7K153061Juno VPAP ST-AResmed, Ltd.20163—
+7K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+7K124041NBM-200MPOrsense, Ltd.20131—
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K123637Hamilton-C3Hamilton Medical AG20124—
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K122324Vpap S-aResmed, Ltd.20120—
+7K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266