# K052208: Glucose Pilot

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin New Bay Bioresearch Co., Ltd.
- Decided: Dec 9, 2005 after 119 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: 1 generation back to K024194 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary whole blood. It is intended for use outside the body (in vitro diagnostic use) by diabetics at home and clinical setting as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K052208
Methodology: https://510kreport.com/methodology