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Dmi Aspirator 500

by Dean Medical Instruments, Inc. 510(k)

Active United States

510(k) K842204

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842204 Date10 Aug 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Dmi Aspirator 500 is a portable aspiration pump, which is a medical device used for suction. It is classified as a class 2 device. The device is used for manual or powered aspiration.

The Dmi Aspirator 500 is supplied with a 1/3HP motor and footswitch. It is available in a single configuration, with a sample container and 115VAC power. The device has FDA 510K clearance, with a decision description of substantially equivalent, and is regulated under regulation number 878.4780.

Questions

AI-generated answers, 26 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 Dmi Aspirator 500 used for?

    The Dmi Aspirator 500 is used for manual or powered aspiration, providing a portable solution for suction needs.

  • Is the Dmi Aspirator 500 a single-use device?

    The device data does not specify if the Dmi Aspirator 500 is for single-use or reuse, but it is designed as a portable aspiration pump.

  • What configuration is the Dmi Aspirator 500 available in?

    The Dmi Aspirator 500 is available in a single configuration, with a sample container and 115VAC power, and is supplied with a 1/3HP motor and footswitch.