510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+3K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K140049Moves SLCThornhill Research, Inc.20141—
+3K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+3K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+3K130411740 SelectCas Medical Systems, Inc.20136—
+3K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+3K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+3K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+3K120052CvinsightIntelomed, Inc.20120—
+3K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+3K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+3K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+3K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K112190Patient MonitorMediana Co., Ltd.20110—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K110953Visensia, Visensia with AlertObs Medical201117—
+3K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K103166Cheetah ReliantCheetah Medical, Inc.20111—
+3K100040BioharnessZephyr Technology Corporation20103—
+3K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+3K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+3K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+3K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+3K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+3K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+3K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+3K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+3K090801Electronic House CallExpress MD Solutions, LLC20093—
+3K083325N-600X with SPD, Oximax N-600XCovidien200953—
+3K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+3K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+3K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+3K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+3K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+3K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+3K073203Carescape V100Ge Medical Systems Information Technologies200720—
+3K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+3K071606Biosign Central StationObs Medical20070—
+3K063814BP-200 PlusSchiller AG20077—
+3K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+3K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+3K061112Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation20060—
+3K051907InnocorInnovision A/S20064—
+3K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+3K051375Vital Signs MonitorMediana Co., Ltd.20053—
+3K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+3K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+3K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+3K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+3K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+3K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003290—
+3K030611Modification to Suzanne Portable Polysomnograph SystemNellcor Puritan Bennett (Melville), Ltd.20030—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+4K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+4K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K222597BabySat 3Owlet Babycare, Inc.20230—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K213911Microstream CO2 NanoPodCovidien, LLC20220—
+4K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+4K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+4K200160740 SafeSATZoe Medical, Inc.20210—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K190561NICU V'02Cosmed Nordic Aps20200—
+4K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+4K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+4K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+4K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+4K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+4K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+4K170820Capnograph and OximeterCmi Health, Inc.20181—
+4K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+4K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—