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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: MDM FDA class 1

    Instrument, Manual, Surgical, General Use

    General, Plastic Surgery

    View full classification →

    The general use manual surgical instrument is a hand-held general and plastic surgery device used during operative procedures for tissue manipulation, cutting, grasping, or retraction, encompassing a broad category of non-powered surgical tools. It is classified as FDA Class I under 21 CFR 878.4800 within the General and Plastic Surgery specialty, subject only to general controls. The product code is MDM and the device is not GMP-exempt. It is not implanted and does not sustain life.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
    FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
    EUTROCHAR
    ANDREWS INTRODUCER, MODEL ASI01
    MICROVASIVE PULMONARY GUIDEWIRE
    LIGHT SABER INTRODUCER NEEDLE
    CHESS HAND SURGERY SYSTEM
    SAPHLIFT
    ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
    TUNNELER
    DERMAVBLADE(TM)
    EAST WEST INSTRUMENTS
    APEX DISPOSABLE INSTRUMENTS
    DEEP SUTURE
    CLAMPS AND CLIPS
    SURGICAL INSTRUMENT, DISPOSABLE
    ACU-DISPO-CE(TM)
    ACU-HEMOSTATIC RING
    DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH
    HOSPITAL KIT DK 117
    SUTUREMATE
    DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC
    HOSPITAL KIT GP 103
    SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
    HOSPITAL KIT EP 104
    BREAST STABILIZER
    ORC ENDOSCOPIC INSTRUMENT HOLDER
    AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS
    PERSONNA SAFETY SCALPEL
    CENTURION DISPOSABLE INSTRUMENTS
    DISPOSABLE CURETTE
    LACERATION REPAIR TRAY
    FRAY BIO-PUNCH
    DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE
    DISPOSABLE FORCEPS
    DISPOSABLE SCISSORS
    SURGICAL INSTRUMENT STAND
    QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
    QUALTEX SUTURE BOOTIES
    JAIN SUTURE/VESIBAND ORGANIZER
    YANKAUER SUCTION DEVICE
    SHAVE PREP TRAY
    SILICONE IMPLANTS
    THE EQUALIZER

    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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