510(k) Report

Devices descending from K012451

280 later devices reach Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+4K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+4K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+4K192514Patient MonitorEdan Instruments, Inc.202061
+4K190273T3 Platform softwareEtiometry, Inc.201914—
+4K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+4K173510BioStamp nPointMc10, Inc.20180—
+4K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+4K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K170497V10Mediana Co., Ltd.201711
+4K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K171244PhysiotraceNimbleheart, Inc.20170—
+4K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+4K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+4K161056Telemetry TransmitterEdan Instruments, Inc.201702
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+4K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+4K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K140502Zoll E Series AlsZOLL Medical Corporation20141—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+4K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+4K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+4K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+4K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+4K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+4K081574Zoll R SeriesZOLL Medical Corporation20088—
+5K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+5K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K241397HinscopeHinlab Sas20240—
+5K240558NavoycdsAlgodx AB20240—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K223073AlioAlio, Inc.20230—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K222550Current Health SystemCurrent Health, Ltd.20221—
+5K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K211305ANNE OneSibel, Inc.20216—
+5K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+5K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+5K202336Patient MonitorEdan Instruments, Inc.202131
+5K202306T3 Platform softwareEtiometry, Inc.202013—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+5K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+5K191620Vitls PlatformVitls, Inc.20202—
+5K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+5K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+5K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+5K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+5K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+5K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+5K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—