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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: JCX FDA class 2

    Apparatus, Suction, Ward Use, Portable, Ac-Powered

    General, Plastic Surgery

    View full classification →

    A portable AC-powered ward use suction apparatus is a compact electric suction device used at the patient bedside or in general ward settings to aspirate fluids, secretions, and other materials from wounds or body cavities during patient care. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JCX, regulated under 21 CFR 878.4780, within the General and Plastic Surgery medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MV Flow Aspiration Pump (MVFLOWPMP01)
    Cary
    Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing
    Easycess Aspiration Pump
    120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
    Acare Suction Unit
    IntelliCartTM System
    ZOOM Aspiration Pump
    TWBM Pump
    DV-300 Aspirator
    IntelliCart System
    Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
    IntelliCartTM System
    Stryker Neptune 3 Waste Management System
    CLIQ DV-300 ASPIRATOR
    SUCTION PUMP
    DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
    IMPACT MODEL 323 ASPIRATOR
    CLIQ DV-300 ASPIRATOR
    STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
    CARE SU01A SUCTION ASPIRATOR
    AG MASS
    DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
    PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
    PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
    EMG SUCTION UNIT
    VACPLUS SUCTION UNIT
    VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
    BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
    AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
    ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
    TRANSPOSAL ULTRA SYSTEMS
    SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701
    EMG AC/DC SUCTION UNIT
    BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
    EMG MODEL SUA01 SUCTION UNIT
    OLYMPUS SUCTION PUMP, MODEL KV-5
    REDON SET
    DEVILBISS SUCTION UNIT
    THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT
    CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
    LSU 2000 PORTABLE SUCTION UNIT
    VACPLUS
    SURE-FLO IRRIGATION Y TUBING SET
    ANNELID
    MODEL 2200 THORACIC SUCTION PUMP
    MODEL 2000 MILD INTERMITTENT SUCTION PUMP
    MODEL 2300 GENERAL PURPOSE SUCTION PUMP
    MODEL 2100 MILD INTERMITTENT SUCTION PUMP
    SCHUCO-VAC MODEL 178

    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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