510(k) K252769

Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) by Shenzhen Finicare Co., Ltd. — Product Code DXN

K252769 is an FDA 510(k) premarket notification submitted by Shenzhen Finicare Co., Ltd. for the device "Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Finicare Co., Ltd. has at least 5 other 510(k) clearances on record.