BEUDAMED
    Product Code: KSP FDA class 1 21 CFR 864.9225

    Apparatus, Cell-Freezing And Reagents

    Hematology

    This device is a cell-freezing apparatus with reagents used to cryopreserve red blood cells or other cellular components using cryoprotective agents, enabling long-term frozen storage of rare blood types or autologous blood for future transfusion. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KSP, regulated under 21 CFR 864.9225 within the Hematology specialty. No special flags apply.

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    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KSP
    Device Class
    FDA class 1
    Regulation Number
    864.9225
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K881465 CRYOBIOLOGICAL FREEZER

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.