510(k) Report

Devices descending from K072369

21 later devices reach Evolution Blood Glucose Monitoring System through their predicates, nearest generation first.

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