510(k) Report

Devices descending from K000126

560 later devices reach Masimo Set Radical Pulse Oximeter with Satshare, Masimo… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+1K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp.2003519—
+1K022037Xltek Sleep SystemExcel Tech., Ltd.20020—
+1K013792Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp.2001227—
+1K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesMasimo Corp.200145—
+1K011851Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo Corp.20010—
+2K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+2K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+2K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+2K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+2K053269Masimo Set Rad-8 Pulse OximeterMasimo Corporation200583—
+2K042346LNCS Oximetry SensorsMasimo Corporation20041—
+2K041815LNCS Oximetry SensorsMasimo Corp.200486—
+2K041204NC SP02 Adapter CableMasimo Corp.20040—
+2K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312—
+2K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+2K033998Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp.20040—
+2K040214Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Masimo Corp.2004254—
+2K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Masimo Corp.20042791
+2K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerPhilips Medical Systems, Inc.20041863
+2K033349AC-1 SP02 Adaptor Cable, Model AC-1Masimo Corp.20042—
+2K033298SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp.200395—
+2K032537Draeger MICRO2+ and Masimo MinisatDraeger Medical Systems, Inc.20030—
+3K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+3K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+3K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+3K121912E1 Ear SensorsMasimo Corporation20124—
+3K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+3K100225Pulse Oximeter Model P10Mediana Co., Ltd.20113—
+3K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+3K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K092838Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation200938—
+3K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+3K083448Cable, Transducer, Model 2400GNConmed Corporation20090—
+3K083719LNCS Oximetry SensorsMasimo Corporation20092—
+3K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+3K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc.20090—
+3K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+3K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc.20090—
+3K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.200925—
+3K083622LNCS Oximetry SensorsMasimo Corporation20091—
+3K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+3K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+3K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+3K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+3K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+3K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc.20084—
+3K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+3K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+3K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+3K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation2006225—
+3K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+3K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+3K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+3K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200591
+3K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+3K050252AC-1 Adapter Cable, 8 Pin and 12 Pin PhilipsMasimo Corporation20050—
+3K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+3K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249—
+3K050068Lnopv AD-L and PD-L Oximetry SensorsMasimo Corporation20050—
+3K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation20052441
+3K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+4K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+4K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+4K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc.20161—
+4K152659V10Mediana Co., Ltd.20162—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150095ReDs Wearable SystemSensible Medical Innovations, Ltd.20151—
+4K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K124041NBM-200MPOrsense, Ltd.20131—
+4K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+4K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+4K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc.20132—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+4K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+4K123309Giraffe and Panda WarmersOhmeda Medical20130Class I