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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: IYT FDA class 2

    System, Rebreathing, Radionuclide

    Radiology

    View full classification →

    A radionuclide rebreathing system is used in nuclear medicine to deliver radioactive gases or aerosols to patients for ventilation lung imaging studies, enabling assessment of pulmonary function and airflow distribution. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is IYT, regulated under 21 CFR 892.1390, within the Radiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Patient Administration Set
    XENON CIRCUIT
    XENON GAS BREATHING CIRCUIT
    XENON CIRCUIT
    TETLEY PATIENT ADMINISTRATION SET
    BOLUS XENON CIRCUIT
    AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
    AMICI XENON ADMINISTRATION SET
    AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE
    DISPOSABLE RESPIRTORY KIT (MP-200)
    MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
    MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
    DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
    DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
    AERO-MIST NEBULIZER
    VENTI-SCAN II
    AMICI KRYPTON ADMINISTRATION SYSTEM*
    AERO-VENT AEROSOL UNIT
    AMICI XENON REBREATHING SYSTEM*
    MODEL XE-103 XENON/MASTER II
    VENTICIS II
    MP-066 RADIOAEROSOL KIT
    MP-066-M RADIOAEROSOL KIT
    MP-070-M RADIOAEROSOL KIT
    MP-070 RADIOAEROSOL KIT
    MP-30XM-IE FACE MASK AND FILTER KIT
    MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
    MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
    MEDIPART DRIERITE MP-1002
    MEDIPART LUNG AEROSOL KIT MP-1012A-M
    MEDIPART LUNG AEROSOL KIT MP-1024A
    MEDIPART LUND AEROSOL KIT MP-1024A-M
    MEDIPART LUNG AEROSOL KIT MP-1012A
    MEDIPART FACE MASK MP-XM-I
    MEDIPART FACE MASK & FILTER MP-30XM-I
    RESPIR GARD-II FACE MASK CORRUGATED TUBING
    XEN-REX I
    MEDIPART XENON BREATHING KIT MP-02XM-I
    MEDIPART XENON BREATHING KIT MP-OIXM-I
    XENON XE 127/XE 133 GAS DISPENSER
    MEDIPART XENON BREATHING KIT MP-01XM
    MEDIPART XENON BREATHING KIT MP-02XM
    XENAMATIC SERIES OF XENON REBREATH DEV
    XENON DELIVERY SYSTEM
    KRYPTON MASKS & TUBING
    MEDI/NUCLEAR #XE-102 XENON/MASTER
    DISPENSOR, XENON GAS
    DISPENSER, GAS XENON

    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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