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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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples
    Product Code: MEG FDA class 2

    Syringe, Antistick

    General Hospital

    View full classification →

    The antistick syringe is a general hospital device designed with features to prevent accidental needlestick injuries during or after injection procedures, protecting healthcare workers from sharps-related exposure to bloodborne pathogens. It is classified as FDA Class II under 21 CFR 880.5860 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MEG and the device is not implanted. Full GMP compliance is required.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
    VaporShield
    SaviSafe Safety Device
    Shina Syringe; Shina Safety Syringe
    Medline Safety Insulin and TB Syringes
    Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
    PowerPAK Syringe
    SafeR Syringe and SafeR Sting
    Disposable Automatically Retractable Safety Syringes (with detachable needle)
    Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
    Sterile Hypodermic Syringes for Single Use with Safety Needles
    Safety Insulin Syringes
    Jeesung Safety Syringe and Single Use Needles
    Automatically Retractable Safety Syringe
    Disposable Automatically Retractable Insulin Safety Syringe
    Sterile Syringe with Fixed Safety Needle for Single Use
    Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles
    Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
    Sterile Auto-Disable Syringes with/without Needle for Single Use
    Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
    Sterile Syringe With Safety Needle
    DR Safety Syringe, Sterile Hypodermic needle for Single use
    Insulin Syringe, Insulin Syringe with Safety Retractable
    TK Insulin Syringe with/without Saftey Retractable Device
    Retractable Safety Insulin Syringe
    Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
    Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
    Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
    Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
    Greenmedi Safety Filter Syringe
    Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
    Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Sterile Hypodermic Safety Syringes for Single Use
    NovaGuard SA Pro Safety System
    0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
    Jeesung Safety Syringe and Single Use Needles
    U&U Insulin Syringe with/without Safety Retractable Device
    Safety Auto-Disable Syrine with Needle (Auto-Lock)
    Disposable Safety Self-destructive Syringes, 5 ML
    Safe'n'Sound Staked Passive Delivery System - Plajex version
    Disposable sterile needle retractable safety syringe
    3S Safety Syringe with/without Needle
    3S Safety Insulin Syringe
    ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
    AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
    SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
    NOVAGUARD S A SAFETY SYSTEM
    SOL-GUARD INSULIN AND TUBERCULIN SAFETY 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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump