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

    NovaLine Tubing Sets for Hemodialysis

    K Number: K201866 · Decision Mar 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    246

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NovaLine Tubing Sets for Hemodialysis
    K Number
    K201866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bain Medical Equipment (Guangzhou) Co., Ltd.
    Date Received
    July 7, 2020
    Decision Date
    March 10, 2021
    Product Code
    FJK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

    Similar 510(k) Clearances

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

    NovaLine Tubing Set for Hemodialysis (BL 124)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VITAL Tubing Sets for Hemodialysis

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Moda-flx Hemodialysis System™ Cartridge (102121-001 )

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CombiSet Hemodialysis Blood Tubing Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tablo Cartridge

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.

    K Number Device Name
    K252423 NovaLine Tubing Set for Hemodialysis (BL 124)
    K240164 NovaLine SP-C35 Transducer Protector (956007)
    K213015 DORA Disposable A.V. Fistula Needle Sets
    K203524 Surgical Masks
    K163025 DORA Disposable A.V. Fistula Needle Sets
    K161582 DORA Tubing Sets for Hemodialysis