510(k) Report

Devices descending from K072698

34 later devices reach Confidant 2.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+1K101806Aidera Diasend SystemAidera AB20102—
+1K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+1K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+1K090886RTX 3371Tunstall Healthcare20092—
+1K083221Aidera DiasendAidera AB20093—
+1K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+1K083331Confidant, Model 2.6Confidant, Inc.20092—
+2K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+2K132618Onetouch RevealLifescan, Inc.20130—
+2K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+2K132148S HealthSamsung Electronics Co., Ltd.20130—
+2K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+2K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+2K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+2K113446Vignet Telehealth ManagerVignet, Inc.20128—
+2K111922Vocare Myhealth TabletVocare, Inc.20110—
+2K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+2K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+2K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+2K110334Waldo Patient MonitorWaldo Health20111—
+2K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+3K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+3K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+3K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+3K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+3K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+3K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+3K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+3K122333Mobilecare MonitorAframe Digital, Inc.20120—
+4K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+4K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+4K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+4K132173Family HealthwareSanitas, Inc.20140—