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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: KPO FDA class 2

    Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

    Gastroenterology, Urology

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    This device is a dialysate concentrate for hemodialysis, available in liquid or powder form, which is diluted with purified water to prepare the dialysis solution used to remove waste products and excess fluid from the blood in patients with kidney failure. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPO, regulated under 21 CFR 876.5820 within the Gastroenterology and Urology specialty. This device is designated as life-sustaining or life-supporting, reflecting its essential role in renal replacement therapy.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    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)
    HemoCare Bicarbonate Concentrate Set (BCS)
    pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
    NxStage PureFlow Solution
    pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
    Citric Complete Liquid Citric Acid Concentrate
    NIKKICART
    Hemo-Lyte C Cartridge
    Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
    HMB32 Dialysis Solution
    Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
    Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
    Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
    NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
    Isopure Dry Acid Dissolution System
    CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
    Citric Complete Dry Citric Acid (45X)
    Citryte
    bibag
    PrismaSATE
    Rockwell Medical CitraPure Acid Concetrate
    HMB32
    MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
    CITRISOL ACID CONCENTRATE
    FRESENIUS DRY ACID DISSOLUTION UNITS
    PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
    ACDS
    SOLCART B
    ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
    PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
    SOLCART B
    FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
    FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
    ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
    MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
    B. BRAUN MODIFIED BICARBONATE DIALYSATE
    MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
    NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
    NXSTAGE PUREFLOW-B SOLUTION
    ACCUSOL DIALYSIS SOLUTION
    B. BRAUN BICARBONATE DIALYSATE
    B.BRAUN PREMIXED DIALYSATE
    NXSTAGE PUREFLOW SOLUTION
    FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
    ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
    BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
    DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
    NXSTAGE PREMIXED DIALYSATE
    DIASOL-ADDITIVES
    DIASOL-BICARB

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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