# K233130: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Dec 20, 2023 after 84 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 K042505 (2005). 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)
- K123669: Transtek Wrist Blood Pressure Monitor, Zhongshan Transtek Electronics Co., Ltd. (2012) Summary page 5.

## Indications for use
The Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 5⅓˝-8½˝). It is intended for adult indoor use only.

Source page: https://510kreport.com/device/K233130
Methodology: https://510kreport.com/methodology