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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: HIF FDA class 2

    Insufflator, Laparoscopic

    Obstetrics/Gynecology

    View full classification →

    The Laparoscopic Insufflator is a device that introduces carbon dioxide gas into the peritoneal cavity to create and maintain a pneumoperitoneum, providing the working space necessary for laparoscopic surgical procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIF, regulated under 21 CFR 884.1730, within the Obstetrics/Gynecology specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AirSurgN Insufflator (10030/AirSurgN)
    High Flow Insufflation Unit (UHI-4)
    TauTona Pneumoperitoneum Assist Device (TPAD)
    VereSee Optical Veres Needle System
    EVA15 insufflator
    TauTona Pneumoperitoneum Assist Device (TPAD)
    Disposable Veress Needles
    AirSeal iFS System; AirSeal dV Solution
    Insufflator (OPTO-IFL1000)
    StarFin
    Insufflator
    Gas Insufflator
    EVA15 insufflator
    LevaLap Laparoscopic Access Device
    AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
    EVA15
    PNEUMOCLEAR
    EVA 15 Insufflator
    GTK Veress Needles
    AP50/30 Insufflator with Insuflow Port
    AirSeal
    GRI-Alleset Veress Needle
    SurgiQuest AIRSEAL iFS System
    TEMED Gas Diffuser
    AP 50/30 Insufflator with Insuflow Port
    HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
    LaparoLight Veress Needle
    PNEUMOCLEAR
    ENDOFLATOR 40, ENDOFLATOR 50
    U-Blade Veress Needle
    S698 Symbioz flow
    Insufflator 50L FM134
    Unimicro Veress Needle
    SurgiQuest AirSeal iFS System
    InsufflatOR Needle
    INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
    PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
    INSUFLOW SYNERGY XL PORT
    HIGH FLOW INSUFFLANTION UNIT
    NEBULAE I
    INSUFLOW SYNERGY PORT
    MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
    CARBONAID C02 DIFFUSER
    HIGH FLOW INSUFFLATION UNIT UHI-4
    MEDLINE PNEUMOPERITONEUM NEEDLE
    VESSEL GUARDIAN
    UNIMAX VERESS NEEDLE
    SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
    VESSEL GUARDIAN
    VASOVAPOR

    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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