# K122482: Transtek Wrist Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Zhongshan Transtek Electronics Co., Ltd.
- Decided: Oct 22, 2012 after 69 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: 1 generation back to K042505 (2005). 1 ancestor in all.
5 later devices descend from it; 1 cites 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)
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N, Omron Healthcare, Inc. (2005) Summary page 1.

## Most influential descendants
- K123669: Transtek Wrist Blood Pressure Monitor (2012), 4 descendants of its own
- 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
This series of devices are digital monitors 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 1/4-8 1/2 inches). This series of devices detect the appearance of irregular heartbeats during measurement and give 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 mmHg. Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K122482
Methodology: https://510kreport.com/methodology