# K092099: NO-Coding Blood Glucose Monitoring System, Models TD-4251, TD-4252, TD-4253 and TD-4254

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 10, 2009 after 149 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 K082482 (2009). 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)
- K082482: Fora TD-4251/U-Right TD-4252/U-Right TD-4254 Blood Glucose Monitoring System, Model TD-4251/TD-4252A/TD-4252B/TD-4254, Taidoc Technology Corporation (2009) Summary page 2.

## Indications for use
FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/, U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/ U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K092099
Methodology: https://510kreport.com/methodology