# K101681: Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995

- Pathway: 510(k) (Abbreviated)
- Applicant: Zhongshan Transtek Electronics Co., Ltd.
- Decided: May 27, 2011 after 346 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 K061822 (2006). 1 ancestor in all.
21 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)
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.

## Most influential descendants
- K120058: Transtek Blood Pressure Monitor (2012), 20 descendants of its own
- 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

## 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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K101681
Methodology: https://510kreport.com/methodology