# K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Aug 2, 2019 after 458 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: 4 generations back to K002115 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130564: Full Automatic (Nibp) Blood Pressure Monitor, Health & Life Co., Ltd. (2013) Summary page 5.
- K123882: Age Automatic Upper Arm Blood Pressure Monitor, Ageless Health Industrial (2013) Summary page 5.

## Most influential descendants
- K193386: Wrist Electronic Sphygmomanometer (2021), 0 descendants of its own

## Indications for use
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm. Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.

Source page: https://510kreport.com/device/K181154
Methodology: https://510kreport.com/methodology