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

    Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

    K Number: K192209 · Decision May 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    120
    Applicant Total
    36
    Review Days
    268

    Basic Information

    Device Name
    Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
    K Number
    K192209
    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
    August 14, 2019
    Decision Date
    May 8, 2020
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

    Similar 510(k) Clearances

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

    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)

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

    HemoCare Bicarbonate Concentrate Set (BCS)

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

    pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)

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

    NxStage PureFlow Solution

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

    pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

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

    Citric Complete Liquid Citric Acid Concentrate

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

    Other Clearances by Fresenius Medical Care Renal Therapies Group, LLC

    K Number Device Name
    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)
    K250404 stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch
    K242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
    K243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
    K232953 AquaBplus; AquaB LITE
    K240394 multiFlux 1000 (F00012408)
    K233950 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
    K232926 Novalung ultimate kit (US)
    Search all 36 clearances from Fresenius Medical Care Renal Therapies Group, LLC →