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
+9K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K221959Q21Neurofield, Inc.20230—
+9K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+9K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K222330The Heart SeatCasana Care, Inc.20230—
+9K223073AlioAlio, Inc.20230—
+9K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K221179SomnoMetryNeumetry Medical, Inc.20223—
+9K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+9K212975MedWandMedwand Solutions, Inc.20221—
+9K211046eCareManager 4.5Visicu, Inc.20220—
+9K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+9K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+9K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K211305ANNE OneSibel, Inc.20216—
+9K210160AlertWatch:ACAlertwatch, Inc.20210—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K210034EnsoSleepEnsodata, Inc.20210—
+9K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+9K202336Patient MonitorEdan Instruments, Inc.202131
+9K202306T3 Platform softwareEtiometry, Inc.202013—
+9K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+9K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+9K191620Vitls PlatformVitls, Inc.20202—
+9K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+9K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+9K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+9K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+9K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+9K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+9K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+9K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+9K180482ZOLL Propaq MZOLL Medical Corporation20182—
+9K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+9K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+9K180017MX40 Release C.01Philips Medical Systems20181—
+9K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+9K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+9K173715AlertWatch:OBAlertwatch, Inc.20180—
+9K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+9K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+9K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+9K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+9K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+9K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+9K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+9K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+9K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+9K153061Juno VPAP ST-AResmed, Ltd.20163—
+9K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+9K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+9K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+9K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+9K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+9K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+9K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+9K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+9K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+9K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+9K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+9K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+9K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+9K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+9K142915ZOLL X SeriesZOLL Medical Corporation20140—
+9K141774Zoll X SeriesZOLL Medical Corporation20142—
+9K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+9K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+9K124041NBM-200MPOrsense, Ltd.20131—
+9K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+9K122715Stellar 150Resmed Germany, Inc.20130Class I
+9K130056Patient MonitorLd Technology, LLC20130—
+9K123511S9 Vpap TXResmed, Ltd.20131—
+9K123637Hamilton-C3Hamilton Medical AG20124—
+9K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+9K122324Vpap S-aResmed, Ltd.20120—
+9K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+9K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+9K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+9K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+9K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+9K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+9K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—