510(k) Report

Devices descending from K973887

1,000 later devices reach Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+5K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+5K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+5K092031Vapor-Clear, Model 100Axon Medical, Inc.201001
+5K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+5K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+5K092217Mercury VCO2Respironics Novametrix, Inc.200904
+5K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+5K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+5K090801Electronic House CallExpress MD Solutions, LLC20093—
+5K083325N-600X with SPD, Oximax N-600XCovidien200953—
+5K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+5K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V.20083Class I
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+5K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+5K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+5K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+5K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+5K073407PacificaOr-Nim Medical, Ltd.20081—
+5K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+5K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+5K073203Carescape V100Ge Medical Systems Information Technologies200720—
+5K071606Biosign Central StationObs Medical20070—
+5K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+5K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+5K063814BP-200 PlusSchiller AG20077—
+5K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+5K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+5K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+5K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+5K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+5K060705Carina HomeDraeger Medical B.V.2006221
+5K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+5K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+5K061112Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation20060—
+5K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+5K051907InnocorInnovision A/S20064—
+5K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+5K053270IVENT 201Versamed Medical Systems, Inc.200687—
+5K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+5K051375Vital Signs MonitorMediana Co., Ltd.20053—
+5K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+5K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+5K050068Lnopv AD-L and PD-L Oximetry SensorsMasimo Corporation20050—
+5K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+5K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+5K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003290—
+5K030611Modification to Suzanne Portable Polysomnograph SystemNellcor Puritan Bennett (Melville), Ltd.20030—
+6K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K252330DeepRESPNox Medical Ehf20250—
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+6K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+6K222597BabySat 3Owlet Babycare, Inc.20230—
+6K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—
+6K222897Enlight 2100Timpel S.A.20232—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K213911Microstream CO2 NanoPodCovidien, LLC20220—
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+6K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+6K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+6K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K190561NICU V'02Cosmed Nordic Aps20200—
+6K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+6K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+6K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+6K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+6K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+6K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+6K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+6K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—