510(k) Report

Devices descending from K950727

75 later devices reach One Touch Profile Complete Diabetes Tracking System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040086Health Buddy with BuddylinkHealth Hero Network, Inc.200447—
+1K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.2002261
+2K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K082020Envision Blood Glucose Test SystemInfopia Co, Ltd.20080—
+2K080639Symphony Glucose Management SystemAnimas Corp.200827
+2K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC200821—
+2K080091Modification to:Health Buddy ApplianceHealth Hero Network, Inc.20081—
+2K070543Modification to Health Buddy ApplianceHealth Hero Network, Inc.20072—
+2K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc.200630—
+2K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc.200639—
+2K050567Health Buddy ApplianceHealth Hero Network, Inc.200540—
+2K042768Medicompass ConnectImetrikus, Inc.20055—
+2K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc.200445—
+3K113764Glucose Meter-Check Solution for InfopiaBionostics, Inc.20120—
+3K103021Element Plus Blood Glucose Monitoring SystemInfopia Co, Ltd.20113—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd.20102—
+3K090405Lipidpro SystemInfopia Co, Ltd.20091—
+3K091430Care Pal, Model CPW-10XDigio2 International Co., Ltd.20090—
+3K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+3K083221Aidera DiasendAidera AB20093—
+3K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.200910—
+3K082590Symphony Meter RemoteLifescan, Inc.20080—
+3K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+3K063484Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc.20064—
+3K062304DLM112 Daylink MonitorRtx Healthcare A/S20068—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K143169MyGlucoHealth Wireless SystemEntra Health Systems20160—
+4K132406Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+4K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+4K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+4K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—
+4K122333Mobilecare MonitorAframe Digital, Inc.20120—
+4K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+4K113670Element Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+4K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+4K111922Vocare Myhealth TabletVocare, Inc.20110—
+4K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+4K110334Waldo Patient MonitorWaldo Health20111—
+4K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+4K101806Aidera Diasend SystemAidera AB20102—
+4K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+4K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+4K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+4K071953RTX3370Rtx Healthcare A/S20073—
+5K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+5K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+5K133997LG SmarthealthLg Electronics20140—
+5K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—
+5K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+5K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+5K132618Onetouch RevealLifescan, Inc.20130—
+5K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+5K132148S HealthSamsung Electronics Co., Ltd.20130—
+5K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+5K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+5K122285Tablet CommanderCardiocom, LLC20125—
+5K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+5K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+5K090886RTX 3371Tunstall Healthcare20092—
+6K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+6K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+6K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K152645Dictum HealthDictum Health, Inc.20166—
+6K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+7K170798Dictum HealthDictum Health, Inc.20175—
+8K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+9K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+10K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+10K240901StethophoneSparrow Acoustics, Inc.20241—
+11K252595Stethophone ProSparrow Acoustics, Inc.20250—