NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)— 510(k) K253089

Shenzhen Best Electronics' NIBP Cuff lists 28 model designations, 14 starting with BCS and 14 starting with BCD. It's filed under product code DXQ, blood pressure cuff, and the record doesn't say how they differ.

Class II, 21 CFR 870.1120. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Shenzhen Best Electronics filed from Shenzhen, China. The decision came 143 calendar days after FDA received it (September 23, 2025 to February 13, 2026), and it was substantially equivalent.