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

    iiSure Infusion Set

    K Number: K261530 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    13
    Review Days
    26

    Basic Information

    Device Name
    iiSure Infusion Set
    K Number
    K261530
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research and Development
    Date Received
    May 8, 2026
    Decision Date
    June 3, 2026
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPA Set, Administration, Intravascular

    Similar 510(k) Clearances

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

    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PuraCath Firefly Needleless Connector IT (9005)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Pump Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ™ IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteadiSet infusion set

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

    Other Clearances by Deka Research and Development

    K Number Device Name
    K261672 twiist Automated Insulin Delivery (AID) System
    K243841 Sparta Infusion Set for Insulin
    K240920 HemoCare Bicarbonate Concentrate Set (BCS)
    K233557 HemoCare Hemodialysis System
    K240256 Remunity System
    K241178 DEKA ACE Pump System
    K234055 DEKA Loop
    K233952 DEKA ACE Pump System
    K232316 DEKA Infusion System, DEKA Administration Set
    K213536 DEKA ACE Pump System
    Search all 13 clearances from Deka Research and Development →