510(k) Report

Devices descending from K951246

430 later devices reach Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+4K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+4K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K170497V10Mediana Co., Ltd.201711
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K161420Moves SLCThornhill Research, Inc.20170—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K161909IQvitals ZoneMidmark Corporation201614
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+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—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K130401Alertwatch: orAlertwatch, LLC20148—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K113045BioharnessZephyr Technology Corporation20122—
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K102047Lci Option for InnocorInnovision A/S201101
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+4K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+4K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+4K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+4K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+4K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+4K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+4K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+4K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+4K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+4K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+4K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+4K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+4K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+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—
+5K230386SpassageQSpass, Inc.20231—
+5K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—