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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
    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
    Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
    Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
    Instylla Delivery Kit
    DuoprossTM Smart Cap (Type I)
    EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    Verisafe Safety Retractable Insulin Syringes
    Merit Syringe
    Sure-Fine Insulin Syringes
    Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec
    BD Plastipak™ Syringe
    Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
    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
    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

    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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