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Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961

by Andon Health Co., Ltd.

510(k) K090769

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 NumberK090769 Date4 Jun 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  • Withdrawn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, 23 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, Model KD-7961 is a non-invasive blood pressure measurement system designed to measure diastolic and systolic blood pressures and pulse rate of an adult individual. It uses an inflatable cuff wrapped around the wrist to perform these measurements.

The device is intended for use by medical professionals or at home. It is supplied as a single-use device and does not require sterilization. The device is not MRI safe. The manufacturer, Andon Health Co., Ltd., has received FDA 510(k) clearance for this product.

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