# K123669: Transtek Wrist Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Zhongshan Transtek Electronics Co., Ltd.
- Decided: Dec 21, 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 K042505 (2005). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122482: Transtek Wrist Blood Pressure Monitor, Zhongshan Transtek Electronics Co., Ltd. (2012) Summary page 1.

## Most influential descendants
- K150908: XM-01 Electronic Automatic Blood Pressure Monitor (2015), 1 descendant of its own
- K233130: Blood Pressure Monitor (2023), 0 descendants of its own
- K222394: Electronic Sphygmomanometers (2023), 0 descendants of its own
- K202599: Transtek Wrist Blood Pressure Monitor (2020), 0 descendants of its own

## Indications for use
Transtek Wrist Blood Pressure Monitor TMB-1014-BT is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4-S8 1/2 inches). This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mml-g. Transtek Wrist Blood Pressure Monitor,. TMB-1014-BT is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K123669
Methodology: https://510kreport.com/methodology