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Filter Void OU812a

by Westmed, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K922492

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00709078050008 UDI-DI Date23 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK922492 Date24 Aug 1992DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Filter
Generic name
Heat/moisture exchanger/microbial medical gas filter
Model / reference
Void OU812a
Primary DI / UDI-DI
00709078050008
510(k) Number
FDA product code
CAH
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K922492)

Show all (12)

Other devices from Westmed, Inc.

See all devices from Westmed, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No