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
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K213911Microstream CO2 NanoPodCovidien, LLC20220—
+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—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+4K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+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—
+4K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+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—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+4K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+4K170182Cardiovit FT-1Schiller AG20170—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K161420Moves SLCThornhill Research, Inc.20170—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+4K152659V10Mediana Co., Ltd.20162—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K151027zensor systemIntelesens Limited20150—
+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—
+4K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+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—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+4K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+4K113045BioharnessZephyr Technology Corporation20122—
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+4K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+4K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+4K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113165Mini-MedicAthena Gtx201213—
+4K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+4K102047Lci Option for InnocorInnovision A/S201101
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+4K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+4K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+4K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+4K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+4K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+4K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K092031Vapor-Clear, Model 100Axon Medical, Inc.201001
+4K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+4K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+4K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—