# K112275: Fora Premium V10 Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 15, 2011 after 129 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: 3 generations back to K070472 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093635: Models Fora V30 and TD-4242 Blood Glucose Monitoring Systems, Taidoc Technology Corporation (2010) Summary page 2.

## Indications for use
The FORA Premium VIG 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring thle effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mnellitus, and is not intended for use on neonates. The alternative site testing in the FORA Premium VIC Blood Glucose Monitoring System canl be used only during steady-state blood glucose conditions. The FORA premium V1O Test Strips are for use with the FORA Premium V 10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samp~les drawn from the fingertip, palm, forearm, upper-armn, calf and thigh. This meter has some speaking functions but is not intended for use by the visually impaired.

Source page: https://510kreport.com/device/K112275
Methodology: https://510kreport.com/methodology