# K063026: OK Meter Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ok Biotech Co., Ltd.
- Decided: Feb 9, 2007 after 130 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: 4 generations back to K945887 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012324: Accu-Chek Active Test System, Roche Diagnostics Corp. (2001) Summary page 1.

## Indications for use
The OK Meter Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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/K063026
Methodology: https://510kreport.com/methodology