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Ster-O-Dose

by Inhalation Therapy Equipment, Co.

510(k) K820227

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820227 Date23 Feb 1982ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0721-2019 FDA Class I initiated 5 Sep 2017
    • Terminated Z-0719-2019 FDA Class I initiated 5 Sep 2017
    • Terminated Z-0720-2019 FDA Class I initiated 5 Sep 2017

    Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

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  • Withdrawn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
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Inhalation Therapy Equipment, Co.

  • Uni-Set

    Class I

  • Ster-O-Mist 1000 Ml

    Class II