510(k) Report

Devices descending from K021819

26 later devices reach One Touch Ultrasmart Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082020Envision Blood Glucose Test SystemInfopia Co, Ltd.20080—
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC200821—
+2K113764Glucose Meter-Check Solution for InfopiaBionostics, Inc.20120—
+2K103021Element Plus Blood Glucose Monitoring SystemInfopia Co, Ltd.20113—
+2K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd.20102—
+2K090405Lipidpro SystemInfopia Co, Ltd.20091—
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.200910—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+3K143169MyGlucoHealth Wireless SystemEntra Health Systems20160—
+3K132406Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+3K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—
+3K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+3K113670Element Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+3K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+4K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+4K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—
+4K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+5K152645Dictum HealthDictum Health, Inc.20166—
+6K170798Dictum HealthDictum Health, Inc.20175—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—