# K061181: Achtung Blood Glucose Monitoring System, Model TD-4207

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jul 6, 2006 after 70 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K062800: Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose Plus Blo (2007), 2 descendants of its own
- K092875: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter (2010), 0 descendants of its own
- K080283: Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring System (2008), 0 descendants of its own
- K080014: Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring System (2008), 0 descendants of its own

## Indications for use
The ACHTUNG Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from 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 ACHTUNG Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Source page: https://510kreport.com/device/K061181
Methodology: https://510kreport.com/methodology