510(k) Report

Devices descending from K062215

35 later devices reach Confidant 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072698Confidant 2.5Confidant, Inc.200734—
+2K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+2K101806Aidera Diasend SystemAidera AB20102—
+2K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+2K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+2K090886RTX 3371Tunstall Healthcare20092—
+2K083221Aidera DiasendAidera AB20093—
+2K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+2K083331Confidant, Model 2.6Confidant, Inc.20092—
+3K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+3K132618Onetouch RevealLifescan, Inc.20130—
+3K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+3K132148S HealthSamsung Electronics Co., Ltd.20130—
+3K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+3K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+3K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+3K113446Vignet Telehealth ManagerVignet, Inc.20128—
+3K111922Vocare Myhealth TabletVocare, Inc.20110—
+3K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+3K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+3K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+3K110334Waldo Patient MonitorWaldo Health20111—
+3K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+4K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+4K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+4K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+4K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+4K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+4K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+4K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+4K122333Mobilecare MonitorAframe Digital, Inc.20120—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+5K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+5K132173Family HealthwareSanitas, Inc.20140—