# K072274: Major Iii Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bestgen Biotech Corp.
- Decided: Feb 29, 2008 after 198 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 K964630 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062538: Easy Check Blood Glucose Monitoring System, Diacare Corp. (2007) Summary page 1.

## Indications for use
The MAJOR III Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary blood from the fingertip. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K072274
Methodology: https://510kreport.com/methodology