# K093035: Fora V10 Blood Glucose Monitoring System, Model TD-4244

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 24, 2009 after 85 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 K090404 (2009). 1 ancestor in all.
1 later device descends 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)
- K090404: Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12 Blodo Glucose Monitoring System, Model TD-4247, Taidoc Technology Corporation (2009) Summary page 2.

## Most influential descendants
- K121706: Fora V10 Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The FORA V10 Blood Glucdse Monitoring System, Model TD-4244 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: palm, forearm, upper-arm, calf and 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 V10 Blood Glucose Monitoring System, Model TD-4244 can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K093035
Methodology: https://510kreport.com/methodology
