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
+8K171244PhysiotraceNimbleheart, Inc.20170—
+8K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+8K171322eCareManager 4.1Visicu, Inc.20172—
+8K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+8K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+8K162627EnsoSleepEnsodata, Inc.20179—
+8K161056Telemetry TransmitterEdan Instruments, Inc.201702
+8K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+8K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+8K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+8K153335AlertWatch: ORAlertwatch, LLC20161—
+8K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+8K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+8K150268CerOXOr-Nim Medical, Ltd.20150—
+8K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+8K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+8K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+8K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+8K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+8K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+8K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+8K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+8K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+8K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+8K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+8K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+8K140502Zoll E Series AlsZOLL Medical Corporation20141—
+8K133484Zoll X SeriesZoll Medical Corp20141—
+8K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+8K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+8K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+8K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+8K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+8K131032Philips Suresigns CentralPhilips Medical Systems20131—
+8K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+8K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+8K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+8K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+8K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+8K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+8K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+8K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+8K121225Hamilton-C2Hamilton Medical AG20128Class I
+8K121367Zoll Propaq XMZOLL Medical Corporation201231
+8K113640Stellar 150Resmed Germany, Inc.20121—
+8K113288Vpap ST-aResmed, Ltd.20127—
+8K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+8K112914Vpap TXResmed, Ltd.20110—
+8K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+8K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+8K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+8K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+8K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+8K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+8K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+8K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—
+8K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+8K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+8K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+8K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+8K081845IVENT101Versamed Medical Systems, Inc.20090—
+8K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+8K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+8K081574Zoll R SeriesZOLL Medical Corporation20088—
+8K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+8K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+8K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+8K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+8K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+9K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+9K253274BedDot (G1)Intelligent Dots, LLC20260—
+9K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+9K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+9K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+9K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+9K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+9K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+9K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+9K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+9K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+9K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K241397HinscopeHinlab Sas20240—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+9K240558NavoycdsAlgodx AB20240—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K233216CLEWICU SystemClew Medical, Ltd.20240—
+9K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+9K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+9K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—