# K232713: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Nov 28, 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: 6 generations back to K061822 (2006). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 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 5.

## Most influential descendants
- K240254: Blood Pressure Monitor (TMB-2296-BT) (2024), 2 descendants of its own
- K250415: G0 Blood Pressure Monitoring System (G0) (2025), 1 descendant of its own
- K254000: Happy Health Blood Pressure Monitor (2026), 0 descendants of its own
- K240102: Blood Pressure Monitor (TMB-2287-B) (2024), 0 descendants of its own

## Indications for use
This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 16cm to 36cm (about 6⅓˝-14⅕˝), 22cm to 32cm (about 8¾˝-12½˝), 22cm to 42cm (about 8¾˝-16½˝) or 22cm to 45cm (about 8¾˝-17¾˝). The cuff with arm circumference range of 16~36cm is intended for children older than 6 years old or adults. The cuffs with arm circumference range of 22~32cm or 22~42cm or 22~45cm, which are intended for adult population. It is intended indoor use only.

Source page: https://510kreport.com/device/K232713
Methodology: https://510kreport.com/methodology