# K094005: Fora G31A/TD-4256A  Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 5, 2010 after 128 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: 2 generations back to K070472 (2007). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090187: Fora G30 Blood Glucose Monitoring System, Model TD-4241, Taidoc Technology Corporation (2009) Summary page 1.

## Most influential descendants
- K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272  Blood Glucose Monitoring System (2011), 6 descendants of its own
- K101635: TD-4239 Blood Glucose Monitoring System  and TD-4239 Multi Blood Glucose Monitoring System (2011), 3 descendants of its own
- K143467: FORA GD43 Blood Glucose Monitoring System (2015), 1 descendant of its own
- K113307: GL Goodlife Series Blood Glucose Monitoring Sysmtem (2012), 1 descendant of its own
- K120042: TD-4268 Blood Glucose Monitoring System TD-4268 Multi Blood Glucose Monitoring System (2012), 1 descendant of its own

## Indications for use
FORA G31a/TD-4256A is intended for in vitro 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 testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions. FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31a/TD-4256A glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above. FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31a/TD-4256A Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles. FORA G31b/TD-4256B is intended for in vitro 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 testing sites in the FORA G31b/TD-4256B Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions. FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31b/TD-4256B glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above. FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31b/TD-4256B Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Source page: https://510kreport.com/device/K094005
Methodology: https://510kreport.com/methodology