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Arterial Diagnostic Unit (ADU)

by Medical Electronic Devices, Inc.

510(k) K770115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770115 Date1 Feb 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Arterial Diagnostic Unit (ADU) is a blood flowmeter device used for cardiovascular diagnostics. It is designed to measure blood flow in arterial vessels, providing diagnostic information for cardiovascular conditions.

The device is supplied by Medical Electronic Devices, Inc. and is classified as a Class II medical device under product code DPW. It is regulated under 870.2100 and received FDA 510(k) clearance on February 1, 1977, with the clearance number K770115.

Other devices from Medical Electronic Devices, Inc.

Questions

AI-generated answers, 22 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 Arterial Diagnostic Unit used for?

    The Arterial Diagnostic Unit (ADU) is a blood flowmeter device designed to measure blood flow in arterial vessels, providing diagnostic information for cardiovascular conditions. It helps clinicians assess blood flow patterns in patients with cardiovascular issues.

  • How is the Arterial Diagnostic Unit supplied and what is its regulatory classification?

    The ADU is supplied by Medical Electronic Devices, Inc. and is classified as a Class II medical device under product code DPW. It is regulated under 870.2100 and received FDA 510(k) clearance on February 1, 1977, with clearance number K770115.

  • Is the Arterial Diagnostic Unit reusable or single-use?

    The device data does not specify whether the Arterial Diagnostic Unit is designed for single-use or reuse. This information would be detailed in the device's instructions for use provided by the manufacturer.

  • What sizes and models of the Arterial Diagnostic Unit are available?

    The device data does not provide information about different sizes or models of the Arterial Diagnostic Unit. Specific model variations would be detailed in the manufacturer's product documentation.