510(k) Report

Devices descending from K991823

785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K173510BioStamp nPointMc10, Inc.20180—
+5K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+5K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+5K172890SedLine Sedation MonitorMasimo Corporation20185—
+5K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+5K170497V10Mediana Co., Ltd.201711
+5K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K150268CerOXOr-Nim Medical, Ltd.20150—
+5K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+5K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+5K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+5K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+5K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+5K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+5K140502Zoll E Series AlsZOLL Medical Corporation20141—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+5K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+5K120087ExspironRespiratory Motion, Inc.20128—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+5K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+5K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—
+5K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+5K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+5K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+5K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+5K081574Zoll R SeriesZOLL Medical Corporation20088—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+5K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+5K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+6K243765LuMon (TM) SystemSentec AG20250—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K241397HinscopeHinlab Sas20240—
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K233827OxiWearOxiwear, Inc.20240—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K240558NavoycdsAlgodx AB20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K231625VitalDetectWellvii, Inc.20240—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+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—