# K091168: Glucophone Blood Glucose Test System, Model Igm-0025

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: May 27, 2010 after 400 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: 3 generations back to K942455 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052469: Glucopack, Healthpia America Corp. (2006) Summary page 1.
- K051285: Glucolab Blood Glucose Monitoring System, Infopia Co, Ltd. (2005) Summary page 1.

## Indications for use
Glucophone TM Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. GlucophoneTM Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhoneTM Blood glucose Testing system is for use with a cellular phone. GlucoPhoneTM Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.

Source page: https://510kreport.com/device/K091168
Methodology: https://510kreport.com/methodology