510(k) Report

Devices descending from K021090

426 later devices reach Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+4K220111RespiraSensePmd Solutions20221—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+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
+4K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+4K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+4K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K130401Alertwatch: orAlertwatch, LLC20148—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K130056Patient MonitorLd Technology, LLC20130—
+4K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+4K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+4K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+4K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+4K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K231625VitalDetectWellvii, Inc.20240—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—