# K123780: Transtek Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Zhongshan Transtek Electronics Co., Ltd.
- Decided: Mar 1, 2013 after 81 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 K061822 (2006). 3 ancestors in all.
19 later devices descend from it; 1 cites 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)
- K120058: Transtek Blood Pressure Monitor, Zhongshan Transtek Electronics Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- K131395: Transtek Blood Pressure Monitor (2013), 18 descendants of its own
- 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

## Indications for use
Trianstek Blood Pressure Monitor LS802-E is a digital monitor 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). This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 13 5/g5 mmHg. Transtek Blood Pressure Monitor, LS802-E is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K123780
Methodology: https://510kreport.com/methodology