510(k) K254048

Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) by Shenzhen Urion Technology Co., Ltd. — Product Code DXN

K254048 is an FDA 510(k) premarket notification submitted by Shenzhen Urion Technology Co., Ltd. for the device "Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Urion Technology Co., Ltd. has at least 7 other 510(k) clearances on record.