# K083664: Fora TD-4245  Blood Glucose Monitoring System, TD-4245

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Jan 9, 2009 after 30 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; 1 cites 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
- K100406: Fora V20 Blood Glucose Monitoring System (2010), 1 descendant of its own
- K102049: Clever Choice Voice+ Blood Glucose Monitoring System (2011), 0 descendants of its own

## Indications for use
The FORA TD-4245 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-ann, the calfand the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in m~)llitoring 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-4245 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The FORA TD-4245 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Source page: https://510kreport.com/device/K083664
Methodology: https://510kreport.com/methodology