Cleared Traditional

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)

K253089 · Shenzhen Best Electronics Co., Ltd. · Cardiovascular

Feb 2026

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K253089 is an FDA 510(k) clearance for the 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), a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Shenzhen Best Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 13, 2026, 143 days after receiving the submission on September 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K253089 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2025
Decision Date	February 13, 2026
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DXQ — Blood Pressure Cuff
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1120
Definition	A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.