510(k) K254048— Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

Substantially Equivalent

Shenzhen Urion Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Urion Technology Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2025-12-17
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.