510(k) Report

Devices descending from K982255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+5K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007119—
+5K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+5K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+5K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+5K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+5K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+6K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+6K243765LuMon (TM) SystemSentec AG20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+6K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K233827OxiWearOxiwear, Inc.20240—
+6K214115MightySat -OTCMasimo Corporation20241—
+6K223721Masimo StorkMasimo Corporation20230—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230386SpassageQSpass, Inc.20231—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+6K220111RespiraSensePmd Solutions20221—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+6K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+6K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+6K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K190273T3 Platform softwareEtiometry, Inc.201914—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+6K190792BB-613WPBiobeat Technologies, Ltd.201912—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K181352Loop SystemSpry Health, Inc.201910—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K173510BioStamp nPointMc10, Inc.20180—
+6K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+6K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+6K172890SedLine Sedation MonitorMasimo Corporation20185—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+6K170497V10Mediana Co., Ltd.201711
+6K172226MX40 Release B.07Philips Medical Systems201713—
+6K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+6K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+6K163664Health-e-Connect System with IDAAlr Technologies20170—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K171244PhysiotraceNimbleheart, Inc.20170—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+6K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+6K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K153335AlertWatch: ORAlertwatch, LLC20161—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+6K150268CerOXOr-Nim Medical, Ltd.20150—
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—