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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: MUU FDA class 2

    System, Suction, Lipoplasty

    General, Plastic Surgery

    View full classification →

    A Lipoplasty Suction System is a device used in liposuction (lipoplasty) procedures to aspirate and remove subcutaneous adipose tissue from targeted body areas, using controlled negative pressure delivered through cannulas. It is FDA Class 2, requiring 510(k) clearance, with product code MUU under 21 CFR 878.5040 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
    SyntrFuge System
    Smart Kit Basic, Smart Kit Pro
    REVOLVE ENVI 600 Advanced Adipose System
    Dermapose Refresh
    JTL-250-01
    Progenikine Concentrating System 25 mL System
    KTA Adipose Treatment Kit
    AuraGen 123 Suction Lipoplasty System (A123)
    Automatic Tissue Processing Unit
    LipiVage
    Revolve Envi 600 Advanced Adipose System
    Alma LipoFlow System
    Lipogems System
    Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
    The Red Head Collection Device, The Jordy Connection System
    Ranfac Fat Aspiration Cannula
    Lipogems System
    Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
    LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
    ST'RIM
    The Lipogems System
    SMARTGRAFT 200 SYSTEM
    SMARTGRAFT 30 SYSTEM
    PUREGRAFT 50 SYSTEM
    HYDRASOLVE LIPOPLASTY SYSTEM
    LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
    ADIPREP ADIPOSE TRANSFER SYSTEM
    ORIGINS LIPOHARVESTING SYSTEM
    GID 700
    PUREGRAFT 850/PURE SYSTEM
    FAT CONCENTRATION SYSTEM
    TISSU TRANS FILTRON SYRINGE FILL
    LIPCOLLECTOR II
    CYTORI PUREGRAFT 250/PURE SYSTEM
    TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
    LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
    LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
    LIPOSE FAT TRANSFER SYSTEM
    CYTORI AFT 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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