# K070472: Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood Glucose Monitoring System, SMS-4230

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Mar 15, 2007 after 23 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
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090187: Fora G30 Blood Glucose Monitoring System, Model TD-4241 (2009), 26 descendants of its own
- K094005: Fora G31A/TD-4256A  Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose Monitoring System (2010), 11 descendants of its own
- K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272  Blood Glucose Monitoring System (2011), 6 descendants of its own
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277 (2010), 6 descendants of its own
- K101635: TD-4239 Blood Glucose Monitoring System  and TD-4239 Multi Blood Glucose Monitoring System (2011), 3 descendants of its own

## Indications for use
The Clever Chek TD-4230/ SureChek 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, and is not intended for use on neonates. The alternative site testing in the Clever Chek TD-4230/ SureChek Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K070472
Methodology: https://510kreport.com/methodology