# K223374: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Jun 30, 2023 after 238 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: 6 generations back to K061822 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202891: Blood Pressure Monitor, Guangdong Transtek Medical Electronics Co., Ltd. (2021) Summary page 4.

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches to 17 inches (22 cm to 42 cm). The device is intended for indoor use.

Source page: https://510kreport.com/device/K223374
Methodology: https://510kreport.com/methodology