# K082201: G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A

- Pathway: 510(k) (Traditional)
- Applicant: U. S. Diagnostics, Inc.
- Decided: Feb 20, 2009 after 199 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 K942455 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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 2.
- K984261: Surestep Blood Glucose Monitoring System, Lifescan, Inc. (1999) Summary page 2.
- K021513: Accu-Chek Advantage Module, Roche Diagnostics Corp. (2002) Summary page 2.

## Most influential descendants
- K110435: Easygluco Plus Blood Glucose Monitoring System (2011), 0 descendants of its own

## Indications for use
The G5 Infinity TM Meter device is used along with the G5 Infinity TM Test Strips for the quantitative measurement of glucose'level in whole blood as an aid in monitoring.the. effectiveness of diabetes management in the home by patients-with diabetes'and in. clinical settings by healthcare professionals. G5 Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh. The G5 InfinityTM Blood Glucose Monitoring System is not intended for screening or diagnosis of diabetes and also not for use with neonates.

Source page: https://510kreport.com/device/K082201
Methodology: https://510kreport.com/methodology