BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

    K Number: K253033 · Decision Oct 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    29

    Basic Information

    Device Name
    Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
    K Number
    K253033
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Simplivia Healthcare , Ltd.
    Date Received
    September 22, 2025
    Decision Date
    October 21, 2025
    Product Code
    ONB
    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
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

    Similar 510(k) Clearances

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

    ProSeal™ Transfer Injector (421120, 421130, 421140)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chemfort Female Luer Lock Adaptor

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZeroClear™ Bag Access (423100)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ProSeal™ Vented Universal Vial Adaptor

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

    Other Clearances by Simplivia Healthcare , Ltd.

    K Number Device Name
    K251411 Chemfort Female Luer Lock Adaptor
    K231286 Chemfort® Catheter Adaptor
    K210707 OnGuard2 Chemfort Closed Administration (CADM)
    K201142 TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
    K192866 Chemfort CSTD