# 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

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Jan 30, 2009 after 155 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122307: Diavue Prudential Blood Glucose Monitoring System (2013), 0 descendants of its own
- K092099: NO-Coding Blood Glucose Monitoring System, Models TD-4251, TD-4252, TD-4253 and TD-4254 (2009), 0 descendants of its own

## Indications for use
The FORA TD-4251 /U-RIGHT TD-4252/ U-RIGHT TD-4254 Blood Glucose Monitoring System is 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 lU-RIGHT TD-4252/ U-RIGHT TD-4254 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K082482
Methodology: https://510kreport.com/methodology