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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: FJK FDA class 2

    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

    Gastroenterology, Urology

    View full classification →

    The Blood Tubing Set With and Without Anti-Regurgitation Valve is a set of disposable tubing used to connect the patient's vascular access to the dialyzer during hemodialysis, optionally incorporating a valve to prevent backflow of blood. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJK, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Moda-flx Hemodialysis System™ Cartridge (102121-001 )
    CombiSet Hemodialysis Blood Tubing Set
    Tablo Cartridge
    SANSIN Tubing Sets for Hemodialysis
    NovaLine Tubing Sets for Hemodialysis
    Dimesol Tubing Sets for Hemodialysis
    DORA Tubing Sets for Hemodialysis
    Oxyless Blood Tubing Set
    TABLO CARTRIDGE
    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
    BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
    GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
    BLOOD TUBING SETS (STERILE FLUID PATH)
    BLOOD TUBING SETS (STERILE FLUID PATH)
    GAMBRO CARTRIDGE BLOOD SETS
    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
    EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
    GAMBRO QUICKSET BLOODLINES
    JMS BLOOD TUBING SETS
    RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
    BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
    FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
    HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
    FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
    FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
    EXEL I.V. BLOOD LINE SET
    BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
    EXTRACORPOREAL BLOOD CIRCUIT
    BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
    NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
    HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
    COMBILINES HEMODIALYSIS BLOOD TUBING SET
    ARTERIAL VENOUS BLOOD TUBING SET
    BRAUN HEMODIALYSIS BLOOD CIRCUITS
    TS 564/PF
    CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
    ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
    HEMODIALYSIS BLOOD TUBING SET
    SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
    TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
    HEMODIALYSIS SYSTEM AND ACCESSORY
    NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
    ARTERIAL/VENOUS BLOODLINES
    HAEMOTRONIC BLOOD LINE SET
    BIOPRIME TM KIT
    BLOOD TUBING SET
    LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
    KAWASUMI BLOOD TUBING LINE
    S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
    SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS

    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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