# K202891: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Mar 9, 2021 after 162 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: 5 generations back to K061822 (2006). 5 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131395: Transtek Blood Pressure Monitor, Guangdong Transtek Medical Electronics Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K232713: Blood Pressure Monitor (2023), 4 descendants of its own
- K232621: Blood pressure monitor (2023), 3 descendants of its own
- 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

## Indications for use
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 45cm (about 8¾"-17½"). The device can be used to detect irregular heartbeat. It is intended for adult indoor use only.

Source page: https://510kreport.com/device/K202891
Methodology: https://510kreport.com/methodology