# K143467: FORA GD43 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 7, 2015 after 154 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: 4 generations back to K070472 (2007). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272  Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 4.

## Most influential descendants
- K173505: FORA GTel Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). The FORA GD43 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).

Source page: https://510kreport.com/device/K143467
Methodology: https://510kreport.com/methodology