510(k) Report

Devices descending from K040214

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+1K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc.20090—
+1K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc.20090—
+1K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.200925—
+1K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation2006225—
+2K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc.20161—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+2K140430740 SelectCas Medical Systems, Inc.20141—
+2K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc.20132—
+2K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+2K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+2K093080Metaphor Metabolic MonitorTreymed, Inc.20100—
+2K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation20082191
+2K063140Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200644—
+3K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+3K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+3K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc.20180—
+3K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+3K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—
+3K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+3K124041NBM-200MPOrsense, Ltd.20131—
+3K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+3K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+3K101123Nexfin Model 2Bmeye B.V.201054—
+3K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+3K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+3K082052Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckMasimo Corporation20086—
+3K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation200841—
+3K071024Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200743—
+4K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+4K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+4K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+4K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+4K202851Spo2 SensorJkh USA, LLC20201—
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+4K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+4K173045OximeterShenzhen Greatmade Tech Limited20180—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+4K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+4K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+4K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+4K122381Nexfin Model 2Edwards Lifesciences, LLC201353—
+4K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+4K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+4K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+4K090165Rainbow Resposable Pulse CO-Oximeter Sensors, Models R2C-25, R2-25, R2C-20 and R2-20Masimo Corporation200940—
+4K091057Masimo Rainbow Set Pronto Pulse CO-Oximeter and AccessoriesMasimo Corporation20095—
+4K073024Masimo Rainbow Set Rad 87 Pulse CO-Oximeter and AccessoriesMasimo Corporation20080—
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+5K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+5K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+5K161909IQvitals ZoneMidmark Corporation201614
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+5K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K140188Masimo Root Monitoring SystemMasimo Corporation201458—