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
+5K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+5K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K173510BioStamp nPointMc10, Inc.20180—
+5K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+5K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+5K140502Zoll E Series AlsZOLL Medical Corporation20141—
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+5K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K113653Patient MonitorEdan Instruments, Inc.201212
+5K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+5K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+5K081574Zoll R SeriesZOLL Medical Corporation20088—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, 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—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K241397HinscopeHinlab Sas20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240558NavoycdsAlgodx AB20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K223073AlioAlio, Inc.20230—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K211305ANNE OneSibel, Inc.20216—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+6K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K202306T3 Platform softwareEtiometry, Inc.202013—
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+6K191620Vitls PlatformVitls, Inc.20202—
+6K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001