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Takeda Medical Digital Sphygmomanometer/ UA-741

by A&D Engineering, Inc.

510(k) K872629

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872629 Date15 Sep 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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, 19 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 Takeda Medical Digital Sphygmomanometer/ UA-741 is a digital blood pressure measuring device classified under product code DXN. It is a substantially equivalent device cleared through the FDA 510(k) process.

It was cleared by the FDA on September 15, 1987, under K872629, and is manufactured by A&D Engineering, Inc. The device is intended for use in cardiovascular-related applications as indicated by the advisory committee classification.

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Questions

AI-generated answers, 19 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 Takeda Medical Digital Sphygmomanometer/ UA-741 intended for?

    The device is intended for use in cardiovascular-related applications, as indicated by its advisory committee classification under product code DXN, which reflects its classification for blood pressure measurement in cardiovascular monitoring contexts.

  • How was the Takeda Medical Digital Sphygmomanometer/ UA-741 cleared for market entry?

    The device was cleared through the FDA 510(k) process as a substantially equivalent device, meaning it demonstrated safety and effectiveness by comparison to a legally marketed predicate device, without requiring premarket approval.

  • When did the FDA clear the Takeda Medical Digital Sphygmomanometer/ UA-741?

    The device received FDA clearance on September 15, 1987, under the 510(k) number K872629, as documented in the device's authorization and decision records.

  • Who manufactures the Takeda Medical Digital Sphygmomanometer/ UA-741?

    The device is manufactured by A&D Engineering, Inc., which is listed as the applicant and manufacturer in the device's authorization data, with their address located in San Jose, California.

  • What product code classifies the Takeda Medical Digital Sphygmomanometer/ UA-741?

    The device is classified under product code DXN, which is used by the FDA to categorize devices based on their intended use and technology, in this case corresponding to digital sphygmomanometers for blood pressure measurement.