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
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K152831Spot SkanSkanray Technologies Private Limited20160—
+5K151512Star 60Skanray Technologies Private Limited20160—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+5K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+5K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+5K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc.20141—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131379EarlysenseEarlysense, Ltd.20137—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K120087ExspironRespiratory Motion, Inc.20128—
+5K121424Expression Information PortalInvivo Corporation201224
+5K120173Patient MonitorEdan Instruments, Inc.201210—
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113623Patient MonitorEdan Instruments, Inc.2012152
+5K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+5K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+5K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K101123Nexfin Model 2Bmeye B.V.201054—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082052Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckMasimo Corporation20086—
+5K082242Icon, Model C3Osypka Medical, Inc.20080—
+5K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation200841—
+5K071024Modification to: Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200743—
+5K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+6K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+6K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+6K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+6K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+6K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K233827OxiWearOxiwear, Inc.20240—
+6K223721Masimo StorkMasimo Corporation20230—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+6K202851Spo2 SensorJkh USA, LLC20201—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+6K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902