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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: FMF FDA class 2

    Syringe, Piston

    General Hospital

    View full classification →

    The Piston Syringe is a general-purpose medical syringe with a piston mechanism used to aspirate or inject fluids in clinical care settings, including irrigation and medication administration. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMF, regulated under 21 CFR 880.5860 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    3DOSE 1ml Syringe
    GPS Advanced; GPS Advanced Cannula
    GO-PEN®
    GraftGun Universal Graft Delivery System (GDS)
    Insulin Syringes
    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
    Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
    Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
    Tamper Evident Cap
    Disposable Pen Injector Assembly
    GPS Advanced; 5 cc GPS Advanced Cannula
    Allograft Delivery Device (OFAC-C)
    Pen Injector
    Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
    HWJECT Auto-disable syringe
    Insulin Syringe
    Medline Luer Lock Syringes
    SMB Luer lock disposable syringe
    NavaClick Injection System
    Insulin Syringe
    Revital Cady
    EpiZact
    Disposable Sterile Syringe
    VeriSafe Safety sterile syringes
    BD Texium™ Needle-Free Syringe
    Sterile Auto-Disable Syringes with/without Needle for Single Use
    Sterile Syringe Bulk Tray
    A-TAP (previously called Arthrotap)
    Hypodermic Syringes & Needle
    Avitus® DragonWing Large Volume Autograft Delivery System
    Avitus® Precision Autograft Delivery System
    Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
    Sol-Guard Auto-disable Syringe
    EpiFinder
    Sterile Hypodermic Syringe for Single Use
    Disposable Insulin Syringe
    Insulin Syringe
    CompuFlo Epidural Computer Controlled Anesthesia System
    Sofjec
    Insulin syringe with integrated needle DL
    Sterile Syringes for Single Use
    Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
    Medwell Technology Ltd Syringes, various sizes
    Insulin Syringes without needle
    Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
    Sol-M Luer Lock Syringe
    Sterile Hypodermic Syringes for Single Use
    Sterile Hypodermic Syringes for Single Use with Needles
    Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
    Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

    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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