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

    Hemoflow F3 and F4 Dialyzers

    K Number: K190459 · Decision Aug 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    51
    Review Days
    178

    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
    Hemoflow F3 and F4 Dialyzers
    K Number
    K190459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    February 26, 2019
    Decision Date
    August 23, 2019
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

    Similar 510(k) Clearances

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

    NIPRO PUREFLUX-L HEMODIALYZER

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

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

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

    DISPOSABLE STORAGE CAP

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

    ULTRACONCENTRATOR SYSTEM

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

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

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

    IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS

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

    Other Clearances by Fresenius Medical Care Renal Therapies Group, LLC

    K Number Device Name
    K252377 NxStage System One with NxView
    K252459 multiFlux 130 (F00013123); multiFlux 160 (F00013124)
    K253462 NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
    K253518 FX CorAL 40; FX CorAL 50
    K250634 BCM2-Body Composition Monitor
    K250471 AquaC UNO H
    K251851 DIASAFEplusUS (F00013010)
    K252180 Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
    K243237 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
    K243505 5008X Hemodialysis System
    Search all 51 clearances from Fresenius Medical Care Renal Therapies Group, LLC →