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
+7K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+7K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+7K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+7K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+7K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+7K180269Cadwell Apollo SystemCadwell Industries, Inc.20182—
+7K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+7K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+7K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+7K170182Cardiovit FT-1Schiller AG20170—
+7K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+7K161420Moves SLCThornhill Research, Inc.20170—
+7K163065T3 SoftwareEtiometry, Inc.201715—
+7K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+7K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+7K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+7K160981Patient MonitorEdan Instruments, Inc.201681
+7K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+7K153156eCareManager 4.0.1Visicu, Inc.20163—
+7K153046Hamilton-MR1Hamilton Medical AG20160Class I
+7K152659V10Mediana Co., Ltd.20162—
+7K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+7K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+7K152552Patient MonitorEdan Instruments, Inc.201621
+7K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+7K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+7K152831Spot SkanSkanray Technologies Private Limited20160—
+7K151512Star 60Skanray Technologies Private Limited20160—
+7K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+7K150992Vios Monitoring SystemVios Medical, Inc.20157—
+7K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+7K151027zensor systemIntelesens Limited20150—
+7K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+7K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+7K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+7K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+7K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+7K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH20141—
+7K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+7K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+7K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+7K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+7K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+7K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+7K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+7K130401Alertwatch: orAlertwatch, LLC20148—
+7K131379EarlysenseEarlysense, Ltd.20137—
+7K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+7K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+7K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+7K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+7K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+7K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+7K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+7K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+7K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+7K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+7K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+7K120087ExspironRespiratory Motion, Inc.20128—
+7K113045BioharnessZephyr Technology Corporation20122—
+7K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+7K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+7K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+7K120574Hamilton-C1Hamilton Medical AG20123—
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—
+7K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+7K120670Hamilton-T1Hamilton Medical AG201211Class I
+7K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+7K113165Mini-MedicAthena Gtx201213—
+7K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+7K102047Lci Option for InnocorInnovision A/S201101
+7K102063Health-E-Connect SystemAlr Technologies20111—
+7K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+7K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+7K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+7K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+7K103167Stellar 150Resmed Germany, Inc.201120—
+7K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+7K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+7K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+7K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+7K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+7K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+7K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+7K093895Ally Platform SystemContinuity Health Solutions20100—
+7K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+7K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+7K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+7K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+7K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+7K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+7K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+7K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+7K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—