# K254048: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: May 14, 2026 after 148 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 K042505 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231367: Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221), Shenzhen Finicare Co., Ltd. (2023) Summary page 5.

## Indications for use
The Wrist Watch Electronic Blood Pressure Monitor uses the oscillometric method to measure diastolic blood pressure, systolic blood pressure. It is intended for use in adults with a wrist circumference between 15-21 cm who do not have arrhythmias (such as atrial fibrillation) and who are not pregnant. The values are for reference purposes and do not constitute a diagnosis.

Source page: https://510kreport.com/device/K254048
Methodology: https://510kreport.com/methodology