BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BD BACTEC FXI Culture System

    K Number: K260213 · Decision May 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    67
    Applicant Total
    1
    Review Days
    125

    Basic Information

    Device Name
    BD BACTEC FXI Culture System
    K Number
    K260213
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BD Diagnostic Systems
    Date Received
    January 23, 2026
    Decision Date
    May 28, 2026
    Product Code
    MDB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MDB System, Blood Culturing

    Similar 510(k) Clearances

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

    BD BACTEC™ Myco/F Lytic Culture Vials

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD BACTEC™ Plus Aerobic/F Culture Vials

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BACT/ALERT MP Reagent System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BacT/ALERT FA Plus; BacT/ALERT PF Plus

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all