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Copal UA-512 Digital Blood Pressure Monitor

by Takeda Medical, Inc.

510(k) K852564

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 NumberK852564 Date19 Aug 1985ClearedStatusActive

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  • Withdrawn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, 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 Copal UA-512 Digital Blood Pressure Monitor is a noninvasive blood pressure measurement device designed to automatically measure and display systolic, diastolic, and mean arterial pressure. It falls under the classification of a digital sphygmomanometer, providing accurate readings through oscillometric technology for clinical and home use.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K852564) with a traditional review process. It is intended for use in clinical settings, including cardiovascular monitoring, and requires proper calibration and maintenance as per manufacturer guidelines. No specific sterility or MRI safety information is provided in the available data.

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