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)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K253089 ↗

FDA Product Code

DXQ

FDA applicant

Shenzhen Best Electronics Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Coyinmed

  Class I

  CE/MDR

• ECG Cable and Leadwires

  Class I

  CE/MDR

• Spo2 Adapter Cable

  Class I

  CE/MDR

• EKG Cable and Leadwires

  Class I

  CE/MDR

• Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

  Class II

  FDA 510(k) K253109 Active Cleared 7 Jan 2026

• NIBP Adapter Hose Tube

  Class I

  CE/MDR

See all devices from Shenzhen Best Electronics Co., Ltd →

• Are these NIBP cuffs designed for single-use or can they be reused?

  These NIBP cuffs are reusable accessories and are supplied in multiple sizes to accommodate different patient populations, including neonates, infants, children, and adults. Since they are intended for repeated use in clinical settings, proper cleaning and maintenance are essential to ensure accuracy and hygiene.

• What patient populations can these cuffs measure blood pressure for, and how do I choose the right size?

  The NIBP cuffs are designed for neonates, infants, children, and adults, with 28 available sizes to ensure proper fit. The correct size is determined by the patient’s arm circumference—selecting the wrong size can lead to inaccurate readings. Refer to the manufacturer’s sizing guide to match the patient’s arm size with the appropriate model (e.g., BCS or BCD series).

• How do I know if a cuff is compatible with my blood pressure monitor?

  These cuffs are designed to work with noninvasive blood pressure monitors that use an internal bladder and air hose (either single or double tube) for inflation/deflation. Compatibility depends on the monitor’s cuff interface—check your device’s manual or consult the manufacturer to confirm if it accepts standard NIBP cuffs with these specifications. The BCS and BCD series are interchangeable in function but may vary in size.

• What regulatory pathways have these cuffs undergone, and what does that mean for clinical use?

  The NIBP cuffs have received FDA 510(k) clearance (K253089) under the Cardiovascular (CV) advisory committee and MDR authorization in the EU. The clearance confirms they are substantially equivalent to a predicate device, meaning they meet FDA safety and performance standards for noninvasive blood pressure measurement. This allows their use in clinical settings where cardiovascular monitoring is required, provided they are used according to the manufacturer’s instructions.

• How should these cuffs be stored to maintain their accuracy and longevity?

  Since these cuffs are reusable, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation of materials. After use, ensure they are thoroughly cleaned and dried to avoid contamination or damage to the bladder or tubing. Follow the manufacturer’s guidelines for maintenance to preserve functionality and accuracy over repeated use.