BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Lifemotion Disposable Membrane Oxygenator

    K Number: K253838 · Decision Mar 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    1
    Review Days
    105

    Basic Information

    Device Name
    Lifemotion Disposable Membrane Oxygenator
    K Number
    K253838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifemotion Medical Technology Co., Ltd.
    Date Received
    December 1, 2025
    Decision Date
    March 16, 2026
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all