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DeVilbiss Suction Unit

by Sunrise Medical Hhg, Inc. 510(k)

Active United States

510(k) K982304

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982304 Date25 Sep 1998ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-2246-2016 FDA Class II initiated 23 May 2016

    A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

    • Terminated Z-2319-2013 FDA Class II initiated 7 Mar 2013

    End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.

    • Terminated Z-0863-2009 FDA Unclassified (pre-2012) initiated 27 Oct 2008

    Improper suction: Regulator knob does not turn properly which can affect the suction level.

Specification

510(k)

510(k) Number
FDA Product Code
JCX
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 DeVilbiss Suction Unit is an apparatus for suction, designed for ward use and portable operation. It is AC-powered and manufactured by Sunrise Medical Hhg, Inc. This device is classified under product code JCX and is intended for general and plastic surgery applications.

The DeVilbiss Suction Unit is supplied as a Class II medical device with FDA 510(k) clearance under number K982304, granted on September 25, 1998. It is regulated under number 878.4780 and was reviewed by the General and Plastic Surgery advisory committee. The device is manufactured at 100 Devilbiss Dr., Somerset, PA 15501.

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