Nam Tai Electronic Blood Pressure Meter

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

Full name

Namtai Electronic Blood Pressure Meter

510(k) Number

K924210 ↗

FDA Product Code

DXN

FDA applicant

Nam Tai Electronics (Canada) , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Namtai

  Class II

  FDA 510(k) K935652 Active Cleared 29 Dec 1993

• Namtai

  Class II

  FDA 510(k) K935872 Active Cleared 24 Jan 1994

• What types of settings can the Nam Tai Electronic Blood Pressure Meter be used in, and how does the single-use or reusable feature affect its application?

  The Nam Tai Electronic Blood Pressure Meter is designed for use in clinical, home, or ambulatory settings. Its single-use or reusable variants allow flexibility depending on the environment: single-use models are ideal for clinical or high-hygiene settings where contamination risk is a concern, while reusable models are better suited for home or ambulatory use where repeated measurements are needed over time. The choice between single-use and reusable depends on infection control protocols and patient care requirements.

• How is the Nam Tai Electronic Blood Pressure Meter supplied, and does sterility vary by model?

  The Nam Tai Electronic Blood Pressure Meter is supplied as either a sterile or non-sterile unit, depending on the specific model variant. Sterility is a key differentiator for clinical settings where infection control is critical, while non-sterile models may be more practical for home or ambulatory use. Always refer to the manufacturer’s documentation for the correct model variant and handling instructions.

• What cuff sizes or models are available for the Nam Tai Electronic Blood Pressure Meter, and how does this affect its use?

  The device description does not specify exact cuff sizes or model variants beyond its ability to measure blood pressure via oscillometric detection on either the upper arm or wrist. The choice of cuff size (e.g., adult, pediatric, or wrist-sized) would typically depend on the patient’s anatomy and the intended use case, such as clinical, home, or ambulatory settings. Confirming the correct model variant with the manufacturer ensures proper fit and accurate readings.

• What regulatory pathway was followed for the Nam Tai Electronic Blood Pressure Meter, and what does this mean for its use?

  The Nam Tai Electronic Blood Pressure Meter was cleared through the FDA’s 510(k) process under the Cardiovascular review panel, specifically classified under the System, Measurement, Blood-pressure category (product code DXN). This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for non-invasive blood pressure measurement. The clearance does not imply any specific clinical indication but confirms regulatory compliance for use in measuring systolic and diastolic blood pressure.