# K073030: AG-605 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 21, 2008 after 269 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K024194 (2003). 1 ancestor in all.
15 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 1.

## Most influential descendants
- K093262: AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring System (2010), 11 descendants of its own
- K110017: AG-608N Blood Glucose Monitoring System (2012), 10 descendants of its own
- K120813: Blood Glucose Monitoring System (2012), 7 descendants of its own
- K123935: Ihealth BG5/BG5L Wireless Smart Glucose Monitoring System (2013), 3 descendants of its own
- K153278: Wireless Smart Gluco-Monitoring System (2016), 2 descendants of its own

## Indications for use
AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.

Source page: https://510kreport.com/device/K073030
Methodology: https://510kreport.com/methodology