# K092875: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: Aug 13, 2010 after 329 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: 4 generations back to K021239 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Taidoc Technology Corporation (2007) Summary page 2.

## Indications for use
ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter 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, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mnellitus at home as an aid in monitoring the effectiveness of diabetes control program. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. For ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter, 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 5.31"- 8.66". The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.

Source page: https://510kreport.com/device/K092875
Methodology: https://510kreport.com/methodology