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

    DIASAFEplusUS (F00013010)

    K Number: K251851 · Decision Oct 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    116
    Applicant Total
    51
    Review Days
    115

    Basic Information

    Device Name
    DIASAFEplusUS (F00013010)
    K Number
    K251851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    June 16, 2025
    Decision Date
    October 9, 2025
    Product Code
    FIP
    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
    FIP Subsystem, Water Purification

    Similar 510(k) Clearances

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

    AquaC UNO H

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

    AquaA

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

    UPT Series Medical RO Water Treatment System

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

    AquaBplus; AquaB LITE

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

    AQUAbase nX

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

    RenaPure Endotoxin Retentive Filter

    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
    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
    K243786 Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
    Search all 51 clearances from Fresenius Medical Care Renal Therapies Group, LLC →