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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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

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    Product Code: PNG FDA class 2

    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

    Gastroenterology, Urology

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    The Peritoneal Drainage Catheter For Refractory Ascites, Long-Term Indwelling (product code PNG) is a Class 2 gastroenterology and urology device intended for long-term drainage of refractory ascites from the peritoneal cavity, regulated under 876.5630. It requires 510(k) clearance and is flagged as both an implant and a life-sustaining/life-supporting device, given its indwelling role in managing refractory ascites. The device falls within the gastroenterology and urology specialty.

    510(k) Clearances

    15 matches
    K Number
    Device Name
    ASEPT® Glide Peritoneal Drainage System
    PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-
    Passio Pump Drainage System
    ASEPT Peritoneal Drainage System
    Aspira Peritoneal Drainage System
    PleurX Peritoneal Catheter System
    Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
    PleurX Peritoneal Catheter System
    Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
    PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
    PLEURX PERITONEAL CATHETER SYSTEM
    ASPIRA PERITONEAL DRAINAGE SYSTEM
    ASEPT PERITONEAL DRAINAGE SYSTEM
    ASPIRA PERITONEAL DRAINAGE SYSTEM
    PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

    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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