510(k) Report

Devices descending from K012891

548 later devices reach Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+3K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+3K152659V10Mediana Co., Ltd.20162—
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+3K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+3K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+3K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+3K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+3K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+3K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+3K102715Regional OximeterNonin Medical, Inc.201053—
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+3K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+3K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+3K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+3K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+3K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+3K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+3K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+3K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+3K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+3K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+3K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+3K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+3K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+4K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+4K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+4K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+4K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K214115MightySat -OTCMasimo Corporation20241—
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+4K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+4K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+4K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+4K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+4K181352Loop SystemSpry Health, Inc.201910—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K170497V10Mediana Co., Ltd.201711
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+4K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+4K151027zensor systemIntelesens Limited20150—
+4K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+4K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+4K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+4K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+4K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+4K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302