510(k) Report

Devices descending from K031330

519 later devices reach Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+3K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+3K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+3K093080Metaphor Metabolic MonitorTreymed, Inc.20100—
+3K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+3K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+3K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+3K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+3K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+3K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+3K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+3K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+3K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+3K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+3K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+3K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+3K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+3K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…Osypka Medical, Inc.20083—
+3K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation20082191
+3K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+3K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+3K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+3K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+3K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+3K063140Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200644—
+3K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+3K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+3K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+3K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+3K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+3K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+3K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation2006226—
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+3K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+3K052961The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors…Philips Medical Systems2005180—
+3K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234—
+3K051439Lnop Blue Oximetry SensorMasimo Corporation200539—
+3K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+4K220111RespiraSensePmd Solutions20221—
+4K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+4K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+4K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+4K180479ReDS SystemSensible Medical Innovations, Ltd.20190—
+4K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc.20180—
+4K170497V10Mediana Co., Ltd.201711
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+4K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+4K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+4K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K130401Alertwatch: orAlertwatch, LLC20148—
+4K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+4K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+4K120087ExspironRespiratory Motion, Inc.20128—
+4K121912E1 Ear SensorsMasimo Corporation20124—
+4K121424Expression Information PortalInvivo Corporation201224
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+4K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+4K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+4K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+4K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—