# K131395: Transtek Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
- Decided: Jun 19, 2013 after 35 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: 4 generations back to K061822 (2006). 4 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123780: Transtek Blood Pressure Monitor, Zhongshan Transtek Electronics Co., Ltd. (2013) Summary page 1.

## Most influential descendants
- K202891: Blood Pressure Monitor (2021), 10 descendants of its own
- K161886: Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device (2016), 7 descendants of its own
- K212115: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (2022), 5 descendants of its own
- K232713: Blood Pressure Monitor (2023), 4 descendants of its own
- K232621: Blood pressure monitor (2023), 3 descendants of its own

## Indications for use
Transtek Blood Pressure Monitor L$802-B, LS805-B, and TMB-1018-BT are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9-17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. These Blood Pressure Monitor compare average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS802-B, LS805-B, and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K131395
Methodology: https://510kreport.com/methodology