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Fully Automatic Electronic Blood Pressure Monitor, Model KD-5904

by Andon Health Co., Ltd.

510(k) K083318

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 NumberK083318 Date29 Jan 2009ClearedStatusActive

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  • Withdrawn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 non-invasive blood pressure measurement system designed to measure the diastolic and systolic blood pressures and pulse rate of adult individuals. It utilizes oscillometric methodology and silicon integrated pressure sensor technology to provide accurate readings.

This device is intended for use by medical professionals or at home and is supplied with a cuff circumference of 22cm-48cm, suitable for a wide range of arm sizes. It can store up to 60 measurements with date and time, and is authorized under FDA 510K clearance with product code DXN.

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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 KD-5904 blood pressure monitor used for?

    The KD-5904 is a non-invasive blood pressure measurement system designed to measure diastolic and systolic blood pressures and pulse rate of adult individuals. It can be used by medical professionals or at home.

  • What cuff size is included with the KD-5904 blood pressure monitor?

    The device is supplied with a cuff circumference of 22cm-48cm, making it suitable for a wide range of adult arm sizes.

  • How many measurements can the KD-5904 blood pressure monitor store?

    The KD-5904 can store up to 60 measurements with date and time stamps, allowing users to track their blood pressure history over time.

  • What technology does the KD-5904 blood pressure monitor use for measurements?

    This monitor utilizes oscillometric methodology and silicon integrated pressure sensor technology to provide accurate blood pressure readings.