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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: BSY FDA class 1

    Catheters, Suction, Tracheobronchial

    Anesthesiology

    View full classification →

    The Catheters, Suction, Tracheobronchial are flexible catheters inserted through the mouth, nose, or tracheostomy tube to remove secretions from the trachea and bronchi, maintaining airway patency. They are classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BSY, regulated under 21 CFR 868.6810 in the Anesthesiology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
    AMBU HAND POWER SUCTION PUMP
    DUAL PURPOSE CLOSED CATHETER
    SUCTION CATHETER
    HI-CARE CLOSED SUCTION SYSTEM
    AMSINO SUCTION CATHETER
    TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
    TRACH CARE SET WITH MICROBAN
    NEO 2 LINE SUCTION SYSTEM
    ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
    CATH-GUIDE
    REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
    REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
    PULM O2 SUCTION CATHETER TRAYS
    SUCTION CATHETER KIT, STERILE, SINGLE-USE
    DUAL PURPOSE CATHETER
    CONNECTING TUBE
    TRIGUARD(TM) SUCTION SYSTEM
    KENDALL MODU-VAC CLOSED SUCTION SYSTEM
    TRACHEAL SUCTION CATHETER
    SUCTION SET, TRACHAEL
    MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
    ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
    ARGYLE ASPIR-FLEX SUCTION CATHETER
    4 SURE TM SUCTION CATHETERS & KITS
    DYNAREX SUCTION CATHETERS & KITS
    ARGYLE AERO-JET SUCTION CATHETER
    STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
    HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
    MECONIUM ASPIRATION
    NEBU-SOL METERED DOSE DISPENSER (TM)
    MUCAID
    MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
    ORAL-CATH SUCTION CATHETER
    TRACH-EZE
    RESU-GARD CATHETER SUCTION
    GENESIS INSUFFLATING CATHETER
    STERI-CATH-DL
    BUSSE BAC/SHIELD
    SUCTION CATHETER, STERILE
    STERI-CATH(TM)
    TRACHAEL SUCTION SET
    SUCTION CATHETER STRAIGHT/COUDE
    SUCTION CATHETER KIT
    MUCOUS TRAP
    NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
    REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
    REPRO-MED NEONATE ASPIRATION SYSTEM
    NU-TRAP SUCTION CATHETER W/MUCUS TRAP
    MUC-X

    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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