# K061073: Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 2, 2006 after 46 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K012636 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042005: Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222, Taidoc Technology Corporation (2004) Summary page 1.
- K012636: Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100, Vsm Technology, Inc. (2001) Summary page 1.

## 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
- 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-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a 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 system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pluse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4 inches to - 13.8 inches.

Source page: https://510kreport.com/device/K061073
Methodology: https://510kreport.com/methodology