Microlife Upper Arm Manual Blood Pressure Monitor BP3MR1-H (BP A50)

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

Full name

Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (Bp A50)

510(k) Number

K073397 ↗

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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• Microlife Upper Arm Automatic Blood Pressure Monitor, Model Bp-3BTO-1, with Optional Thermal Printer, Model Pr 1KA1

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• Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)

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See all devices from Microlife Corp. →

• Is this blood pressure monitor designed for single-use or can it be reused over time?

  This device is explicitly labeled as a reusable, non-sterile medical instrument. It is intended for repeated use in both home and clinical settings, provided it is cleaned and maintained according to the manufacturer’s guidelines. Unlike single-use devices, it requires proper care to ensure accuracy and hygiene over time.

• What types of measurements does this blood pressure monitor provide, and how is it operated?

  The Microlife BP3MR1-H measures systolic and diastolic blood pressure as well as pulse rate. It uses a manual inflation method, meaning the user must inflate the cuff by hand rather than relying on an automatic pump. This design allows for precise control over cuff pressure for accurate readings.

• Are there any special storage requirements for this device, or can it be kept under standard conditions?

  No special storage conditions are required for this device. It can be stored under standard environmental conditions, but it must be cleaned and maintained per the manufacturer’s instructions to ensure proper functionality and hygiene. Regular upkeep is necessary for long-term reliability.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  This device received FDA 510(k) clearance (K073397) under the Special Review pathway, specifically within the Cardiovascular (CV) advisory committee. The classification falls under the product code DXN (Upper Arm Blood Pressure Monitor). The review was conducted by the FDA’s Cardiovascular panel.