510(k) Report

Devices descending from K872781

445 later devices reach Easi Lead System Cable Assembly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…Philips Medizin Systeme Böblingen GmbH20260—
+5K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…Unimed Medical Supplies, Inc.20250—
+5K232035ImpalaAliveCor, Inc.20240—
+5K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K220111RespiraSensePmd Solutions20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K213861CER-SCardiocalm Srl20221—
+5K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+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
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+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
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K120087ExspironRespiratory Motion, Inc.20128—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K110809Wireless Monitoring SystemCarefusion 303, Inc.20112—
+5K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+5K110287Philips Ecg Leadwire SetPhilips Medical Systems201151
+5K103646Intellivue MX40 Patient MonitorPhillips Medical Systems2011161
+5K101133Sensometrics SoftwareDpcom AS20100—
+5K102495M3290B Intellivue Information Center Software, Release a.0Philips Medical Systems201077
+5K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+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
+5K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+5K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+5K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741—
+5K062271M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150…Philips Medical Systems200693
+5K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+5K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006711
+5K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+5K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+5K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical…Philips Medical Systems, Inc.200410—
+5K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K243312CER-SCardiocalm Srl20250—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K172226MX40 Release B.07Philips Medical Systems201713—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+6K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+6K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—