# K100406: Fora V20 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: May 11, 2010 after 84 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
Longest line of descent: 1 generation back to K083664 (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)
- K083664: Fora TD-4245  Blood Glucose Monitoring System, TD-4245, Taidoc Technology Corporation (2009) Summary page 2.

## Most influential descendants
- K102049: Clever Choice Voice+ Blood Glucose Monitoring System (2011), 0 descendants of its own

## Indications for use
The FORA V20 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 V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. The FORA V20 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/K100406
Methodology: https://510kreport.com/methodology