510(k) Report

Devices descending from K962603

1,002 later devices reach Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260585Noxturnal WebNox Medical Ehf20260—
+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—
+6K241960DeepRESPNox Medical Ehf20251—
+6K242798AirmodHeroic Faith International, Ltd.20251—
+6K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K223785N9+Nonagon, Ltd.20230—
+6K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+6K202851Spo2 SensorJkh USA, LLC20201—
+6K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+6K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+6K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+6K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+6K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+6K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline20191—
+6K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+6K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+6K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+6K170820Capnograph and OximeterCmi Health, Inc.20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+6K173045OximeterShenzhen Greatmade Tech Limited20180—
+6K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K152258T3 SoftwareEtiometry, Inc.201616—
+6K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+6K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+6K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+6K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+6K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+6K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+6K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+6K140049Moves SLCThornhill Research, Inc.20141—
+6K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+6K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.20143—
+6K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+6K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+6K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+6K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+6K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+6K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+6K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+6K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+6K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+6K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+6K120052CvinsightIntelomed, Inc.20120—
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+6K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+6K121912E1 Ear SensorsMasimo Corporation20124—
+6K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+6K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+6K120173Patient MonitorEdan Instruments, Inc.201210—
+6K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+6K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+6K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+6K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+6K112006Hamilton-TC1Hamilton Medical AG201213—
+6K113653Patient MonitorEdan Instruments, Inc.201212
+6K113623Patient MonitorEdan Instruments, Inc.2012152
+6K112190Patient MonitorMediana Co., Ltd.20110—
+6K111683Flight 60 VentilatorFlight Medical Innovations, Ltd.20114—
+6K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+6K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc.20112Class I
+6K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+6K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+6K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+6K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K110953Visensia, Visensia with AlertObs Medical201117—
+6K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+6K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+6K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+6K103166Cheetah ReliantCheetah Medical, Inc.20111—
+6K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+6K102715Regional OximeterNonin Medical, Inc.201053—
+6K100040BioharnessZephyr Technology Corporation20103—
+6K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+6K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+6K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—