# K093262: AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Andon Medical Co., Ltd.
- Decided: Jul 13, 2010 after 267 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: 2 generations back to K024194 (2003). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073030: AG-605 Blood Glucose Monitoring System, Andon Health Co, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K133790: Ihealth Align Mini Gluco-Monitoring System (2014), 2 descendants of its own

## Indications for use
AG-608, AG-610 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger only. Testing is done outside the body (InVitro diagnostic use). It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.

Source page: https://510kreport.com/device/K093262
Methodology: https://510kreport.com/methodology