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Guardian, Volumetric Control Delivery

by Avi, Inc. 510(k)

Active United States

510(k) K811933

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811933 Date20 Jul 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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United States — FDA 510(k) Active

Recalls

32 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0660-06 FDA Unclassified (pre-2012) initiated 8 Dec 2005 via K811933, on the same 510(k)
    • Terminated Z-0659-06 FDA Unclassified (pre-2012) initiated 8 Dec 2005 via K811933, on the same 510(k)
    • Terminated Z-0658-06 FDA Unclassified (pre-2012) initiated 8 Dec 2005 via K811933, on the same 510(k)

    Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

  • 29 recalls, same reason

    • Terminated Z-0488-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0469-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0476-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0472-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0465-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0470-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0491-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0467-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0473-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0487-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0484-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0489-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0471-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0481-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0474-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0478-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0485-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0483-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0486-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0466-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0479-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0468-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0475-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0477-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0492-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0482-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0464-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0490-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)
    • Terminated Z-0480-05 FDA Unclassified (pre-2012) initiated 3 Dec 2004 via K811933, on the same 510(k)

    Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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