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Babi*plus Pressure Relief Manifold - 10cm H20, 12.5cm H20, 15cm H20

by A Plus Medical

510(k) K110383

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK110383 Date1 Aug 2011ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0009-2020 FDA Class I initiated 14 Jun 2019

    Device vented gas below the stated pressure.

  • 3 recalls, same reason

    • Terminated Z-0020-2020 FDA Class I initiated 30 May 2019
    • Terminated Z-0021-2020 FDA Class I initiated 30 May 2019
    • Terminated Z-0022-2020 FDA Class I initiated 30 May 2019

    Reports of pressure relief manifold venting gas below the standard pressure.

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  • Withdrawn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
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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