510(k) Report

Devices descending from K982255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+6K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+6K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+6K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+6K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+6K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+6K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+6K140502Zoll E Series AlsZOLL Medical Corporation20141—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—
+6K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+6K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+6K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+6K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+6K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+6K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+6K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—
+6K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+6K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+6K081574Zoll R SeriesZOLL Medical Corporation20088—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+6K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K253274BedDot (G1)Intelligent Dots, LLC20260—
+7K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K241397HinscopeHinlab Sas20240—
+7K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+7K240558NavoycdsAlgodx AB20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K232445CSF-4 (CSF-4)Cardiacsense20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K231625VitalDetectWellvii, Inc.20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K223073AlioAlio, Inc.20230—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K220351Polso WatchChronisense Medical, Ltd.20220—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K211046eCareManager 4.5Visicu, Inc.20220—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+7K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K211305ANNE OneSibel, Inc.20216—
+7K210160AlertWatch:ACAlertwatch, Inc.20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105