510(k) Report

Devices descending from K904039

549 later devices reach Reflectance Sensor (RS-10) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc.20025481
+2K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…Covidien, LLC20220—
+2K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…Stryker Sustainability Solutions20220—
+2K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+2K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+2K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+2K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring…Covidien, Formerly Nellcor Puritan Bennett, Inc.2013342
+2K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+2K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc.20070—
+2K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc.2006140—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+2K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc.20060—
+2K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.20053—
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+2K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+2K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+2K050175Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.20052—
+2K042316Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc.20051—
+2K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc.20041—
+2K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc.20042—
+2K032831Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200…Conmed Corporation20041—
+2K041204NC SP02 Adapter CableMasimo Corp.20040—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+2K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc.200301
+2K030930Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc.20034—
+2K022163Welch Allyn Spot Vital Sign Monitor with MP506Welch Allyn, Inc.20020—
+2K022677Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableAlaris Medical Systems, Inc.200202
+2K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+2K021089Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc.200213—
+2K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+2K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002426—
+3K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline20191—
+3K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+3K161909IQvitals ZoneMidmark Corporation201614
+3K160582WiCapAthena Gtx20160—
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+3K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+3K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+3K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+3K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+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—
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+3K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateRenu Medical, Inc.20110—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K103166Cheetah ReliantCheetah Medical, Inc.20111—
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+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—
+3K083325N-600X with SPD, Oximax N-600XCovidien200953—
+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—
+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—
+3K061112Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation20060—
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+3K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+3K051375Vital Signs MonitorMediana Co., Ltd.20053—
+3K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+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—
+3K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.20041083
+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—
+4K213911Microstream CO2 NanoPodCovidien, LLC20220—
+4K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+4K200160740 SafeSATZoe Medical, Inc.20210—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+4K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+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—
+4K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+4K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+4K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+4K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+4K170182Cardiovit FT-1Schiller AG20170—