# K193386: Wrist Electronic Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changkun Technology Co., Ltd.
- Decided: Jan 27, 2021 after 418 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: 5 generations back to K002115 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor, Shenzhen Med-Link Electronics Tech Co., Ltd. (2019) Summary page 4.

## Indications for use
Wrist Electronic Sphygmomanometer 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.

Source page: https://510kreport.com/device/K193386
Methodology: https://510kreport.com/methodology