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DeVilbiss 7305D-D-EXF

by DeVilbiss Healthcare LLC.

DeVilbiss 7305D-D-EXF is a Class II device made by DeVilbiss Healthcare LLC., cleared under FDA 510(k) K982304 on 25 Sep 1998 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00885304008866), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K982304

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885304008866 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982304 Date25 Sep 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982304 decided 25 Sep 1998 Active
  • FDA GUDID UDI-DI 00885304008866 listed 14 Sep 2016 Listed

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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K982304
  2. Recall initiated FDA recalls Z-0863-2009
  3. Recall initiated FDA recalls Z-2319-2013
  4. Recall initiated FDA recalls Z-2246-2016
  5. Listed FDA GUDID 00885304008866

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DeVilbiss
Generic name
Airway suction catheter
Model / Ref / Catalog
7305D-D-EXF
Primary DI / UDI-DI
00885304008866
510(k) Number
FDA product code
JCX
GMDN term
Airway suction catheter
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Airway suction catheter

Cleared under the same submission (K982304)

and 8 more cleared under K982304

Similar devices in this category

Other devices filed under Airway suction catheter.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)