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Avea Ventilator

by Care Fusion

510(k) K103211

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK103211 Date12 May 2011ClearedStatusActive

Recalls

15 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1894-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1888-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1892-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1897-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1895-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1896-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1898-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1899-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1889-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1890-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1893-2016 FDA Class I initiated 17 May 2016
    • Terminated Z-1891-2016 FDA Class I initiated 17 May 2016

    CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

    • Terminated Z-1609-2015 FDA Class I initiated 3 Apr 2015

    A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

    • Terminated Z-2273-2013 FDA Class I initiated 5 Sep 2013

    CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

    • Terminated Z-0510-2012 FDA Unclassified (pre-2012) initiated 8 Sep 2011

    The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.

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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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