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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: FJS FDA class 2

    Catheter, Peritoneal, Long-Term Indwelling

    Gastroenterology, Urology

    View full classification →

    The Long-Term Indwelling Peritoneal Catheter is a surgically placed device designed to provide continuous or repeated access to the peritoneal cavity for patients undergoing peritoneal dialysis over extended periods. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FJS, regulated under 21 CFR 876.5630 in the Gastroenterology and Urology specialty. This device is flagged as an implant, indicating it is placed within or on the body.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
    Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
    FALLER STYLET
    PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
    FALLER TROCAR
    VETA PERITONEAL DIALYSIS CATHETER
    FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
    FLEX-NECK ARC CATHETER
    EMBEDDING TOOL, MODEL TE-1000
    PD CATH
    FLEX-NECK PD CATHETER, INFANT
    MEDIGROUP CATHETER EXTENDER/REPAIR KIT
    MEDIGROUP KEY TUBE
    PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
    ASH ADVANTAGE PERITONEAL CATHETER
    FLEX-NECK PD CATHETER
    ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
    SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
    CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS
    CATH BELT PD CATHETER AND TRANSFER SET HOLDER
    MEDCOMP PERITONEAL DIALYSIS CATHETERS
    INSERTION
    TROCAR (FALLER STYLET)
    TITANIUM CATHETER EXTENDER
    LIFECOIL CATHETER
    PERITONEAL CATHETERS
    PERITONEAL CATHETERS WITH AN ADDED FUNCTION
    TRUDELL BENT CATHETER
    VAS-CATH PERITONEAL DIALYSIS CATHETER
    CHEMO-CATH INTRAPERITONEAL CATHETER
    PERITONEAL DIALYSIS CATHETERS
    SWAN-NECK PERITONEAL DIALYSIS CATHETERS
    LONG TERM PERITONEAL CATHETER
    STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
    GORE-TEX PERITONEAL CATHETERR
    CATHETER REGULAR
    CUFF MATERIAL ON PEDIATRIC SIZE CATH.
    TENCKHOFF PERITONEAL CATHETERS
    MIROMED PERITONEAL DIALYSIS CATHETER
    TENCKHOFF CATHETER
    BETA-CAP II
    CATHETER, RADIOPAQUE TENCKHOFF
    CATHETER, BETA-CAP-PERITONEAL
    BETA CAP SYSTEM
    SHADOW-CATHS
    CATHETER FINGER GRIP
    PERITONEAL DIALYSIS CATHETER
    BETA-CAP

    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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