510(k) Report

Devices descending from K982255

816 later devices reach Model 2000 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+4K102715Regional OximeterNonin Medical, Inc.201053—
+4K100040BioharnessZephyr Technology Corporation20103—
+4K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+4K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+4K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+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
+4K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+4K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+4K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124—
+4K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+4K092217Mercury VCO2Respironics Novametrix, Inc.200904
+4K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+4K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+4K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+4K090801Electronic House CallExpress MD Solutions, LLC20093—
+4K083325N-600X with SPD, Oximax N-600XCovidien200953—
+4K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009945
+4K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20091252
+4K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+4K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20081273
+4K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+4K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+4K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+4K073407PacificaOr-Nim Medical, Ltd.20081—
+4K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+4K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+4K073203Carescape V100Ge Medical Systems Information Technologies200720—
+4K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+4K071606Biosign Central StationObs Medical20070—
+4K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151—
+4K063814BP-200 PlusSchiller AG20077—
+4K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+4K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+4K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154—
+4K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc.2006188—
+4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006176—
+4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006155—
+4K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+4K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc.2006211—
+4K061112Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-MConmed Corporation20060—
+4K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH20062212
+4K051907InnocorInnovision A/S20064—
+4K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222—
+4K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+4K051375Vital Signs MonitorMediana Co., Ltd.20053—
+4K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+4K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+4K050068Lnopv AD-L and PD-L Oximetry SensorsMasimo Corporation20050—
+4K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+4K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+4K031740VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc.2003290—
+4K030611Modification to Suzanne Portable Polysomnograph SystemNellcor Puritan Bennett (Melville), Ltd.20030—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K222597BabySat 3Owlet Babycare, Inc.20230—
+5K222897Enlight 2100Timpel S.A.20232—
+5K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K213911Microstream CO2 NanoPodCovidien, LLC20220—
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K200160740 SafeSATZoe Medical, Inc.20210—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K190561NICU V'02Cosmed Nordic Aps20200—
+5K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+5K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+5K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—