# K061452: TF-BP01 Blood Pressure Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Tung FU Electric Co., Ltd.
- Decided: Jul 12, 2006 after 48 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: 3 generations back to K021239 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051703: Clever TD-3018A Blood Pressure Monitor, Taidoc Technology Corporation (2005) Summary page 1.

## Indications for use
The TF-BPO1TM blood pressure monitor is intended for use in the home to measure systolic and diastolic blood pressures and pulse rate on adults aged 18 and older. Measurements are obtained using a non-invasive technique by placing an inflatable cuff around the wrist. The cuff circumference is 5.25 to 7.75 inches.

Source page: https://510kreport.com/device/K061452
Methodology: https://510kreport.com/methodology