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Non Rebreathing Mask

by Specialty Packaging Producs, Inc.

510(k) K913164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK913164 Date15 Jan 1992ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0746-2021 FDA Class II initiated 11 Nov 2020
    • Terminated Z-0742-2021 FDA Class II initiated 11 Nov 2020
    • Terminated Z-0741-2021 FDA Class II initiated 11 Nov 2020
    • Terminated Z-0744-2021 FDA Class II initiated 11 Nov 2020
    • Terminated Z-0743-2021 FDA Class II initiated 11 Nov 2020
    • Terminated Z-0745-2021 FDA Class II initiated 11 Nov 2020

    There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

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  • Withdrawn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
KGB
Device Class
Class I
Regulation
21 CFR Part 868.5570
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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