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Digital Sphygmomanometer Model UA-833

by A&D Engineering, Inc. 510(k)

Active United States

510(k) K912118

Overview

A digital sphygmomanometer is a non-invasive blood pressure measurement system used in cardiovascular care. The device is designed to measure arterial blood pressure automatically using oscillometric technology.

It is supplied as a reusable device for use in clinical settings. The device received FDA 510(k) clearance K912118 on August 7, 1991, and is classified under product code DXN with regulation 870.1130. It is intended for non-invasive blood pressure measurement in patients.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912118 Date7 Aug 1991ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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  • Expiring
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United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

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

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Questions

  • What is the DIGITAL SPHYGMOMANOMETER MODEL UA-833 used for?

    It is used for non-invasive blood pressure measurement in patients, utilizing oscillometric technology to automatically measure arterial blood pressure in clinical cardiovascular care settings.

  • Is the DIGITAL SPHYGMOMANOMETER MODEL UA-833 reusable or single-use?

    The device is supplied as a reusable system intended for repeated use in clinical environments, not as a single-use disposable product.

  • How was the DIGITAL SPHYGMOMANOMETER MODEL UA-833 authorized for market?

    It received FDA 510(k) clearance under submission K912118 on August 7, 1991, based on a determination of substantial equivalence to a legally marketed predicate device.