# K092688: Fora Poct S10/TD-4258 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jul 6, 2011 after 673 days
- Product code: LFR (Glucose Dehydrogenase, 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: 3 generations back to K031755 (2003). 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)
- K082169: Pro Glucose Test Strip, Taidoc Technology Corporation (2008) Summary page 1.

## Indications for use
The FORA POCT 310 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates. The FORA POCT 31 0 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.

Source page: https://510kreport.com/device/K092688
Methodology: https://510kreport.com/methodology