510(k) Report

Devices descending from K982255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+5K170820Capnograph and OximeterCmi Health, Inc.20181—
+5K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+5K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+5K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+5K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K163065T3 SoftwareEtiometry, Inc.201715—
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+5K153156eCareManager 4.0.1Visicu, Inc.20163—
+5K152659V10Mediana Co., Ltd.20162—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+5K152831Spot SkanSkanray Technologies Private Limited20160—
+5K151512Star 60Skanray Technologies Private Limited20160—
+5K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+5K151027zensor systemIntelesens Limited20150—
+5K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+5K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+5K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+5K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+5K150620740 SelectCas Medical Systems, Inc.201501
+5K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+5K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K131379EarlysenseEarlysense, Ltd.20137—
+5K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+5K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+5K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+5K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+5K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+5K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+5K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120087ExspironRespiratory Motion, Inc.20128—
+5K113045BioharnessZephyr Technology Corporation20122—
+5K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+5K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+5K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K113165Mini-MedicAthena Gtx201213—
+5K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+5K102047Lci Option for InnocorInnovision A/S201101
+5K102063Health-E-Connect SystemAlr Technologies20111—
+5K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+5K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+5K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+5K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+5K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K093895Ally Platform SystemContinuity Health Solutions20100—
+5K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+5K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+5K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+5K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+5K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+5K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+5K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+5K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+5K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+5K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+5K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH2008143—
+5K081983M3290A Intellivue Information Center Software, Release 1.00Philips Medical Systems200883
+5K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—