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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: JOL FDA class 2

    Catheter And Tip, Suction

    General Hospital

    View full classification →

    The Catheter and Tip, Suction is a general hospital device consisting of a catheter and its tip used to aspirate secretions, fluids, or debris from the airway, wound, or body cavities to maintain patency and cleanliness during clinical care. This device is FDA Class 2, indicating moderate risk, subject to general and special controls; however, it does not require a 510(k) for all configurations under its current submission type. It carries product code JOL and is regulated under 21 CFR 880.6740, within the General Hospital medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
    STERILE SALINE FOR CATHETER CARE
    STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    GERM TRAPPER SUCTION TUBE HOLDER
    CPR SUCTION CATHETER KIT
    STERILE ISOTONIC SALINE & STERILE WATER
    ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
    THORACENTESIS CATHETER
    CATCO THORACIC CATHETER
    STERILE PHYSIOLOGICAL SALINE/STERILE WATER
    STERILE WATER
    STERILE .9% SODIUM CHLORIDE SOLUTION
    PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
    STERILE .9% SODIUM CHLORIDE FOR IRRATION
    PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
    STERILE WATER FOR IRRIGATION
    PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
    PRE-FILLED SYSRINGE W/STERILE WATER
    SALINE FOR IRRIGATION
    STERILE WATER FOR IRRATION
    GERITREX STERILE SALINE SOLUTION FOR IRRIGATION
    STB YANKAUER SUCKER/NOZZLE
    DISPOSABLE SUCTION PROBE
    THORA-CATH
    STERILE WATER
    GERITREX STERILE WATER FOR IRRIGATION
    VCI SUCTION/IRRIGATION TUBING SET
    SURGICAL SUCTION TIP
    UNIVERSAL IRRIGATION & SUCTION TUBING SET
    ENDOTRACHEAL SUCTIONTUBE
    JAIN BLOOD SHIELD
    PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
    THOROCENTESIS KIT
    STERILE WATER SOLUTION CATALOG # 10000
    CURITY THORACENTESIS TRAY
    KLEEN TEST BASIN SET
    SUCTION TIP
    LAPAROSCOPIC SUCTION PROBE
    GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
    ARROW PNEUMOTHORAX KIT, AK-01500
    URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
    APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
    VAN DELLEN CANNULA
    DEKNATEL THORACIC CATHETER

    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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