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

    Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

    K Number: K250298 · Decision Oct 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    9
    Review Days
    250

    Basic Information

    Device Name
    Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
    K Number
    K250298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, LLC
    Date Received
    January 31, 2025
    Decision Date
    October 8, 2025
    Product Code
    HDB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDB Extractor, Vacuum, Fetal

    Similar 510(k) Clearances

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

    MEDELA SINGLE USE SILC CUP, MODEL 077.0791

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VACULINK, MODEL VCL 3000

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MITYVAC MERLIN, MODEL 10027

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SWIFT LOW PROFILE CUP (PRO CUP)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MITYVAC

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Clinical Innovations, LLC

    K Number Device Name
    K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)
    K223900 babyLance Safety Heelstick (BLM, BLN, BLP)
    K153591 ebb Complete Tamponade System
    K150573 ebb Complete Tamponade System
    K140163 KOALA TOCO
    K131781 CLEARVIEW TOTAL
    K110605 ROM PLUS
    K061539 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE