# K073119: Clever Chek Model TD-4232 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Mar 3, 2008 after 119 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 K063212 (2006). 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)
- K063212: Clever Chek TD-4231 and TD-4223 Blood Glucose Monitoring System, Taidoc Technology Corporation (2006) Summary page 1.

## Indications for use
The CLEVER CHEK TD-4232 Blood Glucose Monitoring System is intended for 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. The alternative site testing in this system can be used only during steady-state blood glucose conditions. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Source page: https://510kreport.com/device/K073119
Methodology: https://510kreport.com/methodology