# K071493: Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209, TD-4222, TD-4225

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Oct 26, 2007 after 149 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 K010362 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060620: Accu-Chek Aviva Test Strips, Roche Diagnostics Corp. (2006) Summary page 1.

## Indications for use
The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the foliowing 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. The alternative site testing in the Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system can be used only during steady-state blood glucose conditions. Professionals may use the Clever Chek TD-4209/ Clever Chek TD-4222 Blood/ Clever Chek TD-4225 glucose monitoring system to test neonatal blood from the heel, but may not be used in screening for neonatal hypoglycemia.

Source page: https://510kreport.com/device/K071493
Methodology: https://510kreport.com/methodology