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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: GCY FDA class 1

    Apparatus, Suction, Single Patient Use, Portable, Nonpowered

    General, Plastic Surgery

    View full classification →

    The Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY) is a disposable, portable, and manually operated suction device used for a single patient to aspirate fluids, secretions, or debris without relying on an external power source, suitable for use in surgical or clinical settings. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4680 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    REDYROB-CLOSED WOUND DRAINAGE SYSTEM
    ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
    CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
    PENROSE DRAIN MODELS 6001 - 6007
    MACRO SUCTION TUBE MODEL NO 10061
    PRESSURE IRRIGATING SYSTEM
    AUTOVAC CLOSED WOUND SUCTION SYSTEM
    BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
    IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
    IMC 5.0MM IRRIGATION/ASPIRATION PROBE
    INMAN POOLE TIP SUCTION PROBE W/TUBING KIT
    POOLE TIP SUCTION PROBE
    5.0 MM IRRIGATION/ASPIRATION PROBE
    ORC TAPPERED IRRIGATING PROBE
    # 9455 AND #9457 POOLE TIP SUCTION PROBE
    ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
    KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
    KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML
    J-VAC BULB SUCTION RESERVOIR
    SOLCOVAC WOUND DRAINAGE SYSTEM
    DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
    MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
    SEROMA-CATH CLOSE DRAINAGE SYSTEM
    INAMED SMALL DRAIN SYSTEM
    INAMED CONVERTIBLE DRAIN SYSTEM
    INAMED CLOSED-WOUND DRAIN SYSTEM
    CLOSED WOUND RESERVOIR
    DRENOVAC
    CLOSED WOUND SUCTION DEVICE
    AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
    HEMO SUC NUMBER HS100-HS205
    WOUND-EVAC RS
    HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
    CLOSED WOUND DRAINAGE SYSTEMS
    MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
    DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
    URESIL 150CC BELLOWS RESERVOIR
    URESIL CLOSED DRAINAGE RESERVOIR
    NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
    ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
    BARD PARKER 150CC BELLOWS RESERVOIR
    EMODREN EXCHANGEABLE PLASTIC BELLOWS
    SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
    ECONOMY 400 CWS WITH PVC DRAINS
    PROVAC WOUND HEALING/SUCTION SET
    CLOSED WOUND DRAIN
    PERIMETER CLOSED WOUND RESEVOIR
    CONCEPT C-VAC
    PROVAC WOUND DRAINAGE & HEALING SYS
    TLS BULB DRAINAGE SYSTEM

    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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