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DeVilbiss 7305P-I

by DeVilbiss Healthcare LLC.

Ref 7305P-I

DeVilbiss 7305P-I is a device classified as Class IIa in the EU and Class II in the US made by DeVilbiss Healthcare LLC., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00885304002390), cleared under FDA 510(k) K982304 on 25 Sep 1998 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00885304002390), withdrawn (EUDAMED), active (FDA 510(k)), not in commercial distribution (GUDID) as of 7 Nov 2026. 3 FDA recalls are linked to it.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K982304

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885304002390 Basic UDI-DI 00885304002390UDI-DIDate30 Oct 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00885304002390 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK982304 Date25 Sep 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885304002390 registered 30 Oct 2026 Withdrawn
  • FDA 510(k) K982304 decided 25 Sep 1998 Active
  • FDA GUDID UDI-DI 00885304002390 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

6 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 00885304002390
  6. Registered EUDAMED B-00885304002390

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vacu-Aide EUDAMED
DeVilbiss GUDID
Generic name
Airway suction catheter
Device name
Suction Unit
Model / Ref / Catalog
7305P-I
Primary DI / UDI-DI
00885304002390
Basic UDI-DI
B-00885304002390
510(k) Number
FDA product code
JCX
EMDN code
A0601010102 Drainage systems with reservoir
GMDN term
Airway suction catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Legacy device (under a directive)
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K982304)

and 8 more cleared under K982304

Similar devices in this category

Other devices filed under DRAINAGE SYSTEMS WITH RESERVOIR.

Other devices from DeVilbiss Healthcare LLC.

See all devices from DeVilbiss Healthcare LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)