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Safeset Reservoir

by Abbott Laboratories 510(k)

Active United States

510(k) K932188

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932188 Date25 Oct 1993ClearedStatusActive

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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  • Expiring
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United States — FDA 510(k) Active

Recalls

16 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-2828-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2817-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2820-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2818-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2821-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2822-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2823-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2813-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2807-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2825-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2815-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)
    • Terminated Z-2811-2016 FDA Class II initiated 10 Aug 2016 via K932188, on the same 510(k)

    ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

  • 4 recalls, same reason

    • Terminated Z-0617-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K932188, on the same 510(k)
    • Terminated Z-0620-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K932188, on the same 510(k)
    • Terminated Z-0618-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K932188, on the same 510(k)
    • Terminated Z-0619-05 FDA Unclassified (pre-2012) initiated 2 Nov 2004 via K932188, on the same 510(k)

    Syringes could possibly allow air to enter the patient's vascular system.

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

Specification

510(k)

510(k) Number
FDA Product Code
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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