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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: OMP FDA class 2

    Negative Pressure Wound Therapy Powered Suction Pump

    General, Plastic Surgery

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    The Negative Pressure Wound Therapy Powered Suction Pump (product code OMP) is a Class 2 surgical device regulated under 21 CFR 878.4780 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is indicated for wound management by applying continual or intermittent negative pressure to remove fluids from chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (including diabetic and pressure ulcers), and flaps and grafts. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RENASYS EDGE (66803126)
    Nisus NPWT Canister 500-mL (CPC-500)
    Wound Geni NPWT System
    Genadyne ASTRA NPWT
    Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
    extriCARE® 1000 Negative Pressure Wound Therapy System
    RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
    Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
    RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
    Genadyne DUO NPWT
    VERSA Negative Pressure Wound Therapy System (VCMPP-100)
    Negative Pressure Wound Therapy Device (V-Move, V-Grand)
    NEXA™ NPWT System
    Renasys Edge
    3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
    Prospera Spectruum Negative Pressure Wound Therapy System
    Carilex VT¿200-i NX
    PREVENT Kit
    Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
    Invia® Integrated Dressing
    Genadyne Hybrid Foam Dressings
    3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
    3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)
    extriCARE 1000 Negative Pressure Wound Therapy System
    RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
    extriCARE® 3000 Negative Wound Pressure Therapy System
    UNO Negative Pressure Wound Therapy System
    Renasys Edge (66803126)
    PWD Negative Pressure Wound Therapy System
    Invia Ease Negative Pressure Wound Therapy (NPWT) System
    Dermatac Drape
    Prevena Restor Adapti-Form Dressing
    Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
    Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
    Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
    PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
    Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
    3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
    Theia NPWT Foam Wound Dressing Kit
    Innomed NPWT Silicone Foam Dressing
    V.A.C.ULTA Negative Pressure Wound Therapy System
    Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac
    Nisus Touch Negative Pressure Wound Therapy Pump
    Avance Solo Negative Pressure Wound Therapy (NPWT) System
    Kendall NPWT Incision Management Device
    PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
    PocketDoc™ Micro Wound Therapy System
    Kendall NPWT Incision Management Dressing Kit
    ACTIV.A.C. Negative Pressure Wound Therapy System
    V.A.C. DERMATAC Drape

    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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