510(k) Report

Devices descending from K040799

67 later devices reach Hommed Genesis Patient Monitor System with Options through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+1K061087Genesis Otc MonitorHoneywell Hommed, LLC200648—
+2K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+2K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+2K120470MIPALWatermark Medical20120—
+2K113165Mini-MedicAthena Gtx201213—
+2K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC201018—
+2K072698Confidant 2.5Confidant, Inc.200734—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+3K141792Genesis Touch SystemHoneywell Hommed20140—
+3K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+3K120325Connected Care Mobile ApplicationWatermark Medical20120—
+3K112858Genesis Touch SystemHoneywell Hommed, LLC201211—
+3K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+3K101806Aidera Diasend SystemAidera AB20102—
+3K103214M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc.20103—
+3K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+3K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+3K090886RTX 3371Tunstall Healthcare20092—
+3K083221Aidera DiasendAidera AB20093—
+3K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+3K083331Confidant, Model 2.6Confidant, Inc.20092—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+4K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+4K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+4K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K141706Ecare Coordinator (Ecc)Visicu, Inc.201422
+4K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+4K132618Onetouch RevealLifescan, Inc.20130—
+4K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+4K132148S HealthSamsung Electronics Co., Ltd.20130—
+4K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+4K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+4K122285Tablet CommanderCardiocom, LLC20125—
+4K113446Vignet Telehealth ManagerVignet, Inc.20128—
+4K120941Constant Care Lilah Home Health Monitoring SystemConstant Care, LLC20121—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+4K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+4K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+5K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+5K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+5K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+5K171029eCareCoordinatorVisicu, Inc.20171—
+5K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+5K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+5K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+5K130360Constant Care Lilah Home Health Monitoring System - Multi-User VersionConstant Care, LLC20130—
+5K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+5K122333Mobilecare MonitorAframe Digital, Inc.20120—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K222398Care Team PortalVivify Health, Inc.20230—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K132173Family HealthwareSanitas, Inc.20140—