# K042005: Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Aug 27, 2004 after 32 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.
26 later devices descend from it; 3 cite it directly.
0 of 27 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
- K060467: Prodigy Blood Glucose Test System (2006), 17 descendants of its own
- K073118: Prodigy Voice Blood Glucose Monitoring System (2008), 14 descendants of its own
- K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268 (2009), 6 descendants of its own
- K122338: Preferred Blood Glucose Monitoring System (2013), 3 descendants of its own
- K053593: Prodigy (2006), 3 descendants of its own

## Indications for use
The Achtung TD-4207 / Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood taken from the finger. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Source page: https://510kreport.com/device/K042005
Methodology: https://510kreport.com/methodology