BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    InstaTRU Instant Biological Indicator for Steam (IBI-05)

    K Number: K251559 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    393

    Basic Information

    Device Name
    InstaTRU Instant Biological Indicator for Steam (IBI-05)
    K Number
    K251559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2806
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    True Indicating, LLC
    Date Received
    May 21, 2025
    Decision Date
    June 18, 2026
    Product Code
    QVB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QVB Biological Sterilization Indicator With Indirect Growth Detection

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVB), ordered by most recent decision date.

    Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by True Indicating, LLC

    K Number Device Name
    K242860 Type 5 Integrating Indicator for Steam (CSPN-15)
    K233413 Ultraphon Chemical Indicator (TRO-T and TRO-B)
    K220778 Chemical Indicator for Steam
    K210481 Instant 20s Indicator
    K200970 Self-Contained Biological Indicator