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Takeda Medical Auto. Ambu. Blood Press. METER/2420

by A&D Engineering, Inc.

510(k) K880079

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 NumberK880079 Date31 Mar 1988ClearedStatusActive

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  • Withdrawn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
DSK
Device Class
Class II
Regulation
21 CFR Part 870.1110
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 Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is an automated blood pressure monitoring device designed for cardiovascular applications. It is a Class II medical device that measures blood pressure automatically, providing accurate readings for clinical assessment.

This device is supplied by A&D Engineering, Inc. and is authorized under FDA 510K clearance with K number K880079. It is regulated under product code DSK and is intended for use in cardiovascular settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

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Questions

AI-generated answers, 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.

  • What is the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 used for?

    The Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is an automated blood pressure monitoring device designed specifically for cardiovascular applications. It provides accurate blood pressure readings for clinical assessment in cardiovascular settings.

  • Is the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 a single-use device or can it be reused?

    The device data does not specify whether the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 is designed for single-use or multiple reuse. No information regarding sterility or reprocessing instructions is provided in the available data.

  • What regulatory approvals does the Takeda Medical Auto. Ambu. Blood Press. Meter/2420 have?

    The device is authorized under FDA 510K clearance with K number K880079. It is classified as a Class II medical device and regulated under product code DSK. The clearance was received on January 11, 1988, with a decision date of March 31, 1988.

  • What are the storage conditions for the Takeda Medical Auto. Ambu. Blood Press. Meter/2420?

    No information regarding storage conditions is provided in the device data. Users should consult the manufacturer's instructions for specific storage requirements to maintain device functionality and accuracy.