Microlife Wrist Watch Blood Pressure Monitor BP3AX1-4U

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

Full name

Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U

510(k) Number

K061403 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Microlife Intellectual Property GmbH →

• What is the Microlife BP3AX1-4U designed for?

  The Microlife BP3AX1-4U is an automated, non-invasive blood pressure monitor designed for self-measurement by trained individuals. It is intended for use in both home and clinical settings to measure arterial blood pressure via an inflatable wrist cuff and electronic sensor. The device provides accurate readings for systolic and diastolic pressure, as well as pulse rate, making it suitable for regular monitoring of cardiovascular health.

• Is the BP3AX1-4U single-use or reusable?

  The primary monitor unit of the BP3AX1-4U is reusable, but the cuff and sensor components may vary in terms of single-use or reusable design depending on the specific configuration. For optimal hygiene and accuracy, it is recommended to follow the manufacturer’s guidelines on cuff and sensor replacement or cleaning. Proper storage in a clean, dry environment is also advised to maintain device performance.

• Does the BP3AX1-4U have any sterility claims?

  The Microlife BP3AX1-4U does not make explicit sterility claims. Since it is primarily intended for home or clinical use by trained individuals, it is not designed or marketed as a sterile device. Users should adhere to standard hygiene practices, such as cleaning reusable components and ensuring proper storage, to minimize contamination risks.

• What regulatory clearance does the BP3AX1-4U hold?

  The BP3AX1-4U holds FDA 510(k) clearance under the Special review pathway, with a clearance date of June 14, 2006. This classification indicates that the device is deemed substantially equivalent to a legally marketed predicate device in terms of technology and performance. The clearance is specific to the regulatory submission filed by Microlife Intellectual Property GmbH and does not imply broader approval for other uses or markets.

• How should the BP3AX1-4U be stored to maintain accuracy?

  To preserve accuracy and hygiene, the BP3AX1-4U should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing the device to moisture or contaminants, as this could affect its performance. Regularly inspect the cuff and sensor components for wear or damage, and replace them as recommended by the manufacturer to ensure reliable blood pressure measurements.