# K121706: Fora V10 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Foracare, Inc.
- Decided: Jan 14, 2013 after 220 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: 2 generations back to K090404 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093035: Fora V10 Blood Glucose Monitoring System, Model TD-4244, Taidoc Technology Corporation (2009) Summary page 2.

## Indications for use
FORA VIG No Code Blood Glucose 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: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but has not been validated for use by visually impaired users. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. This system is intended to be used by a single patient and should not be shared. FORA VIO0 test strips are for use with FORA VI10 No Code Blood Glucose meter model TD-4244 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm calf and thigh. The FORA control solutions can only be used with FOR-A VI10 No Code Blood Glucose meter, model TD-4244 and the FORA VI10 test strips to check that meter and test strips are working together properly. The alternative site testing in FORA VIO No Code Blood Glucose Monitoring systems model TD-4244 can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K121706
Methodology: https://510kreport.com/methodology