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Fully Automatic Electronic Blood Pressure Monitor

by Andon Health Co., Ltd. 17 variants

510(k) K102930

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102930 Date3 Nov 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
FDA applicant
Andon Health Co, Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fully Automatic Electronic Blood Pressure Monitor is a device designed for measuring blood pressure non-invasively. It operates automatically to provide blood pressure readings without requiring manual inflation or operation.

This device is supplied by Andon Health Co., Ltd. and has received FDA 510(k) clearance with product code DXN. It is classified as Class II under Special Controls. The device is available in various models including KD-513 and KD-5811, with different memory capacities and display features.

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health Co., Ltd. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Fully Automatic Electronic Blood Pressure Monitor?

    This device is designed for non-invasive measurement of blood pressure. It operates automatically to provide readings without requiring manual inflation or operation, making it convenient for both clinical and home use.

  • What models are available and what are their differences?

    The device is available in various models including KD-513 and KD-5811. These models differ in memory capacity and display features, allowing users to choose based on their specific monitoring needs.

  • Is this device single-use or reusable?

    The Fully Automatic Electronic Blood Pressure Monitor is designed for repeated use. It is supplied by Andon Health Co., Ltd. and intended for multiple blood pressure measurements over time with proper care and maintenance.

  • What is the regulatory status of this device?

    This device has received FDA 510(k) clearance with product code DXN. It is classified as Class II under Special Controls, indicating it meets specific regulatory requirements for safety and effectiveness.