# K120058: Transtek Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Zhongshan Transtek Electronics Co., Ltd.
- Decided: Jan 31, 2012 after 22 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: 2 generations back to K061822 (2006). 2 ancestors in all.
20 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)
- K101681: Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995, Zhongshan Transtek Electronics Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K123780: Transtek Blood Pressure Monitor (2013), 19 descendants of its own
- 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

## Indications for use
This series of devices 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. The Blood Pressure Monitor compares average blood, pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS-802, TMB-lO0 18, TMB- 101 8-A, TM B-l 12, and TMB-I 112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indlkated.

Source page: https://510kreport.com/device/K120058
Methodology: https://510kreport.com/methodology