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Arm Blood Pressure Monitor - Name:111

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222926

by Shenzhen Yuezhongxing Technology Co., Ltd.

Identifiers

510(k) Number
K222926 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Name:111 FDA 510(k)EUDAMED
Arm Blood Pressure Monitor FDA 510(k)EUDAMED
Model Name: B1681 FDA 510(k)EUDAMED
Arm Blood Pressure Monitor FDA 510(k)EUDAMED
Model Name: B1682 FDA 510(k)EUDAMED
Arm Blood Pressure Monitor FDA 510(k)EUDAMED
Model Name: B1683 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Arm Blood Pressure Monitor, designed to measure and display blood pressure readings non-invasively using an upper-arm cuff. It falls under the category of automated blood pressure monitoring devices, providing systolic and diastolic pressure measurements for clinical or home use.

The monitors (models B1681, B1682, and B1683) are supplied as reusable electronic devices intended for single-patient use per cycle. They are not MRI-safe and require proper calibration and storage in a clean, dry environment. Authorised under FDA 510K and MDR, these devices are classified under product code DXN and are regulated as substantially equivalent to predicate devices.

Frequently asked questions

Are these monitors intended for clinical or home use, and how does that affect their design or usage guidelines?

These Arm Blood Pressure Monitors (models B1681, B1682, and B1683) are designed for both clinical and home use, as they fall under automated blood pressure monitoring devices. Their non-invasive upper-arm cuff design ensures versatility for measuring systolic and diastolic pressure in either setting. Since they are reusable but intended for single-patient use per cycle, clinical users should follow infection control protocols (e.g., cleaning between patients) to maintain hygiene. Home users should store the device in a clean, dry environment to preserve accuracy and longevity.

How should I store these devices to ensure they remain accurate and functional over time?

These monitors require storage in a clean, dry environment to prevent damage or contamination. Since they are reusable but designed for single-patient use per cycle, proper maintenance—including calibration—is essential for accuracy. Avoid exposing them to extreme temperatures, moisture, or direct sunlight, as these conditions could compromise performance. Follow the manufacturer’s guidelines for periodic recalibration to maintain reliable blood pressure readings.

Can these devices be used in an MRI environment, and if not, what precautions should be taken?

No, these Arm Blood Pressure Monitors (models B1681, B1682, and B1683) are not MRI-safe. If used in proximity to MRI machines, they should be removed from the area to avoid interference or damage. The electronic components and cuff mechanism could be affected by magnetic fields, potentially leading to inaccurate readings or device malfunction. Always follow facility protocols for non-MRI-compatible medical devices when near MRI equipment.

What distinguishes these models (B1681, B1682, B1683) from other arm blood pressure monitors, and how are they regulated?

While the exact technical differences between models B1681, B1682, and B1683 aren’t specified, they are all FDA 510(k)-cleared and MDR-authorized under product code DXN, classified as substantially equivalent to predicate devices. This means they meet regulatory standards for automated blood pressure monitors and are reviewed by the FDA’s Cardiovascular (CV) Advisory Committee. Their reusable design with single-patient-use-per-cycle guidelines also sets them apart from disposable alternatives, requiring proper calibration and maintenance for clinical or home use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Yuezhongxing Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K222926 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026