510(k) Report

Devices descending from K120813

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133790Ihealth Align Mini Gluco-Monitoring SystemAndon Health Co, Ltd.20142—
+1K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd.20133—
+2K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.20162—
+2K153286iHealth Align Gluco-Monitoring systemAndon Health Co, Ltd.20160—
+2K150833iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20150—
+3K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring…Andon Health Co, Ltd.20171—
+4K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)Andon Health Co, Ltd.20190—