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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: LYA FDA class 1

    Splint, Intranasal Septal

    Ear, Nose, Throat

    View full classification →

    The Intranasal Septal Splint (product code LYA) is a device inserted into the nasal passages following nasal septal surgery (septoplasty) or nasal fracture repair to support the septum during healing, maintain nasal airway patency, and prevent adhesion formation. Regulated under 21 CFR 874.4780 and classified as a Class 1 device subject only to general controls, it falls under the Ear, Nose, and Throat specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.

    510(k) Clearances

    46 matches
    K Number
    Device Name
    TurbAlign
    Epi-Stop Nasal Gel/epistaxis pack
    SPIWay Endonasal Access Guide
    Novapak Nasal Sinus Packing and Stent
    ChitoZolve
    SPIWay Endonasal Access Guide
    Composite Removable Sinus Stent System
    Chitogel Endoscopic Sinus Surgery Kit
    SPIWay Endonasal Access Guide
    HEMOPORE
    NOVASHIELD INJECTABLE NASAL PACKING AND STENT
    NASOPORE-FD
    ARTHROCARE NASASTENT CMC NASAL DRESSING
    SPIWAY ENDONASAL ACCESS GUIDE
    MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
    POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
    NASAL/EPISTAXIS PACK
    SINEXUS SINUS STENT GEN 2, MODEL 1999-25
    SYNTHEMED DEVICE
    QUIKCLOT NOSEBLEED
    ADVACOAT SINUS GEL AND STENT
    ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
    NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
    MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
    SEPRAGEL SINUS
    HADGEL, 4 GRAM/SYRINGE
    LACTOSORB ETHMOID STENT
    POREX NOSTRIL RETAINERS
    SILIMED NASAL RETAINER
    BIVALVE NASAL SPLINT
    NASAL AIRWAY SPLINT
    DOYLE COMBO NASAL AIRWAY SPLINT
    CUSTOM NASAL SPLINT
    ENT PACKINGS, WICKS, WIPES, AND SPONGES
    C-FLEX SEPTAL SPLINTS
    NASAL SEPTAL SPLINT
    NASAL SPLINT
    BIVONA NASAL TURBINATE STENT
    MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
    MEROCEL MEROSPLINT
    BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
    TURBINATE NASAL SPLINT
    NASAL SEPTAL SPLINT
    INVOTEC BI-VALVE SPLINT
    PASSAGE AIRWAY SPLINT
    FLORET NASAL TAMPON

    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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