510(k) K261929

Upper Arm Blood pressure monitor (BP7155D) by OMRON Healthcare, Inc. — Product Code DXN

K261929 is an FDA 510(k) premarket notification submitted by OMRON Healthcare, Inc. for the device "Upper Arm Blood pressure monitor (BP7155D)". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. OMRON Healthcare, Inc. has at least 10 other 510(k) clearances on record.