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Automatic Digital Blood Pressure Meters, Models

by Sein Electronics Co., Ltd.

510(k) K912588

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 · Traditional NumberK912588 Date19 Dec 1991ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Automatic Digital Blood Pressure Meters are classified as noninvasive blood pressure measurement devices. These instruments automatically inflate and deflate a cuff around the upper arm or wrist to measure systolic and diastolic blood pressure, providing digital readouts for accurate monitoring. Designed for clinical and home use, they eliminate the need for manual sphygmomanometry, reducing user error and improving convenience. The devices are intended for repeated use in various settings, including hospitals, clinics, and patient homes.

These meters are supplied as reusable electronic devices, requiring calibration and maintenance as specified by the manufacturer. They are not sterile and are intended for single-patient use per session, with disposable cuffs recommended for hygiene. No MRI safety information is provided, and sizes are determined by the cuff circumference, typically ranging from pediatric to adult measurements. The devices hold an FDA 510(k) clearance under the product code DXN, with the classification of substantially equivalent to predicate devices, as determined by the Cardiovascular Advisory Committee in 1991.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What are the Automatic Digital Blood Pressure Meters used for?

    These devices are noninvasive blood pressure measurement instruments that automatically inflate and deflate a cuff around the upper arm or wrist to measure systolic and diastolic blood pressure, providing digital readouts for accurate monitoring in clinical and home settings.

  • How are these blood pressure meters supplied and maintained?

    The meters are supplied as reusable electronic devices that require calibration and maintenance as specified by the manufacturer. They are not sterile and are intended for single-patient use per session, with disposable cuffs recommended for hygiene purposes.

  • What sizes are available for these blood pressure meters?

    The devices are available in various sizes determined by the cuff circumference, typically ranging from pediatric to adult measurements to accommodate different patient populations and ensure accurate readings.

  • What is the regulatory status of these blood pressure meters?

    The devices hold an FDA 510(k) clearance under the product code DXN, with the classification of substantially equivalent to predicate devices, as determined by the Cardiovascular Advisory Committee in 1991.