# 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

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jan 12, 2007 after 115 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 K021239 (2002). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061181: Achtung Blood Glucose Monitoring System, Model TD-4207, Taidoc Technology Corporation (2006) Summary page 1.
- K042795: Clever Chek TD-3213, Taidoc Technology Corporation (2005) Summary page 1.
- K061073: Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250, Taidoc Technology Corporation (2006) Summary page 1.

## Most influential descendants
- K092875: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter (2010), 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 Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose plus Blood Pressure 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 systems can be used only during steady-state blood glucose conditions. The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. For Clever Chek TD-3213/ Clever Chek TD-3215/ Dr. T TD-3216/ Clever Chek TD-3217 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" - 7.75". For Clever Chek TD-3250 system, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" - 13.8".

Source page: https://510kreport.com/device/K062800
Methodology: https://510kreport.com/methodology