# K124040: Foracare GD20 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 16, 2013 after 139 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: 1 generation back to K101631 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101631: Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 2.

## Indications for use
The ForaCare GD2O Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from the finger, palm, forearm and upper arm,). It is intended for use by a single person and should not be shared. The ForaCare GD2O Blood Glucose Monitoring System is intended for self-testing use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. It should not be used for the diagnosis of or screening for diabetes, or for testing of neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The ForaCare GD20 test strips are for use with the ForaCare GD2O meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm and upper arm.

Source page: https://510kreport.com/device/K124040
Methodology: https://510kreport.com/methodology