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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: FYD FDA class 2

    Apparatus, Exhaust, Surgical

    General, Plastic Surgery

    View full classification →

    A surgical exhaust apparatus is a ventilation device used in operating rooms to remove contaminated air, particulate matter, aerosols, or anesthetic gases from the immediate surgical environment, improving air quality and infection control. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYD, regulated under 21 CFR 878.5070, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PlumeSafe X5 Smoke Management System
    8Q10 Surclear Smoke Plume Evacuation System
    Medline Smoke Evacuation Shroud
    NEBULAE SRS Laparoscopic Surgical Smoke Removal System
    Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
    EvaQMax Smoke Evacuation System
    Megadyne Foot Switch
    SafeAir Smoke Evacuator compact
    Smoklean
    Crystal Vision
    RapidVac Smoke Evacuator System
    VISICLEAR SMOKE EVACUATION SYSTEM
    CONMED AER DEFENSE SMOKE EVACUATOR
    SERVICE MANAGER SM40SE
    LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
    MASTEL LASER CLEAN ROOM, MODEL EBS-100
    LAFACI
    SMOKE EVACUATION HOSES/TUBING
    NEPTUNE WASTE MANAGEMENT STSTEM
    CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
    PENADAPT 10
    NEPTUNE WASTE MANAGEMENT SYSTEM
    PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
    BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
    BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
    BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
    STERIS SMOKE EVACUATION SYSTEM
    VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
    SKYVAL
    SMARTVAC SMOKE EVACUATION SYSTEM
    FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
    BUFFALO FILTER REPLACEMENT FILTER #BSPF030
    BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
    BEI MEDICAL SYSTEMS' SMOKE EVACUATOR
    SNJ SMOKE EVACUATION SUCTION WAND
    CRYSTAL VISION AND ACCESSORIES
    ACU-EVAC
    BUFFALO FILTER REPLACEMENT FILTER #BST300UL
    BUFFALO FILTER REPLACEMENT FILTER #BPTU100
    REUSABLE TOWEL AND GOWN PACKS
    PLUMEMASTER SMOKE EVACUATION SYSTEM
    BUFFALO FILTER REPLACEMENT FILTER #BCULPA
    BUFFALO FILTER REPLACEMENT FILTER #BCCHAR
    BUFFALO FILTER REPLACEMENT FILTER #BCR0030
    BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
    BUFFALO FILTER REPLACEMENT FILTER #BCR0043
    VICROSAFE 6 AND VICROSAFE 12
    BUFFALO FILTER REPLACEMENT FILTER BST312PF
    BUFFALO FILTER REPLACEMENT #BLFS-101/103

    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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