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Disposable Medication Nebulizer

by Hospitax

510(k) K801867

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801867 Date20 Aug 1980ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1044-2016 FDA Class II initiated 11 Nov 2015

    The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LCQ
Device Class
Class II
Regulation
21 CFR Part 862.3450
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent