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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: MMK FDA class 2

    Container, Sharps

    General Hospital

    View full classification →

    The Sharps Container is a rigid, puncture-resistant disposal container designed for the safe collection and disposal of used needles, syringes, lancets, and other sharp medical instruments to prevent needlestick injuries and reduce the risk of bloodborne pathogen transmission among healthcare workers and the public. Classified as a Class 2 device under 21 CFR 880.5570 within the General Hospital specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PureWay 1.4 Quart Sharps Collector
    Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
    Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
    Qlicksmart BladeFlask UNIVERSAL
    Promisemed Sharps container
    Nitta M&T Safety Box
    Tiger Reusable Sharps Container
    Sharps container
    Tiger Sharps Containers
    OnSite Waste Sharps Container
    Maxcon Sharps Container
    Maxcon Two Gallon Chemotherapy Container
    HealthBeacon HB2 Sharps Bin
    MAUSER PG II Sharps Container
    Med-Tainer Single Deposit Container
    Red2Green Reusable Sharps Container
    Oak Ridge Products Sharps Containers
    NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
    MEDLINE SHARPS CONTAINERS
    PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
    MedSource Sharps Dart
    B TRAVELSAVVY SHARPS CONTAINER
    OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
    SHARPS CONTAINER
    BWCSH-1 SHARPS CONTAINER
    MEDLINE SHARPS CONTAINER
    ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
    STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
    SHARPSOLOGY 2
    SHARPSCAN
    SHARPSTANK REUSABLE SHARPS CONTAINER
    OAK RIDGE PRODUCTS SHARP CONTAINER
    SHARPS TANK REUSABLE SHARPS CONTAINER
    BD RECYKLEEN SHARPS COLLECTORS
    SHARPS CONTAINER
    SHARPS CONTAINER
    SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
    SHARP CHUTE
    ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.
    ENVIRO SHARP SOLUTIONS 3
    SHARPS COMPLIANCE CONTAINER
    GONGDONG DISPOSABLE SHARP CONTAINER
    D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
    SHARPS TRANSPORT TUBE, MODEL 50035
    ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
    AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
    SHARPS AWAY DISPOSABLE CONTAINER
    ON THE GO SHARPS
    SEKURIT SHARPS COLLECTION CONTAINER
    SHARPS CONTAINER, MODEL 039-413

    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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