# K081715: Fora TD-4244 & TD-4245  Blood Glucose Monitoring Systesm

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 17, 2008 after 182 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The FORA TD-4244 Blood Glucose Monitoring System is intmded for use in the quantitative measurement of glucose in fresh capillary whole blood :from the finger BOd the following alternative s~es: the palm, the forearm. the upper-arm, the calf and the thigh. It is .intended for use by healtbcm professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not iDteildCd for the diagnosis ofor screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glUC0ge conditions. The FORA ID-4244 Blood Glucose Monitoring System contains a speaking functicmality which provides step by step instnJctions to aid visually impaired persons.

Source page: https://510kreport.com/device/K081715
Methodology: https://510kreport.com/methodology