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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: FCM FDA class 2

    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    Gastroenterology, Urology

    View full classification →

    The Sterile Urethral Catheterization Tray With or Without Catheter (product code FCM) is a procedure kit providing all sterile supplies necessary for urethral catheterization, and may include the catheter itself. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.5130 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
    Self-Cath Closed System
    AMSELF CLOSED CATHETERIZATION SYSTEM
    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
    AMSURE URETHRAL CATHETERIZATION TRAY
    AMSURE FOLEY INSERTION TRAY
    THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
    RUSCH MMG/O'NEIL CATHETER
    MENTOR SELF-CATH CLOSED SYSTEM
    THE O'NEIL STERILE FIELD URINARY CATHETER KIT
    SELF CATH SET/SAFETY CATH
    RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
    NHMC URETHRAL CATHETERIZATION TRAY
    URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
    UNIVERSAL DRAINAGE TRAY
    CPR URETHRAL CATHETER TRAY
    CPR FOLEY CAHTETER KIT
    NHMC FOLEY CATHETERIZATION TRAY
    CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
    URETHRAL CATHETERIZATION TRAY
    UROLOGICAL CATHETER & ACCESSORIES
    HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
    CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
    CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
    FOLEY CATHETERIZATION TRAY
    MON-A-THERM FOLEY KIT
    TOUCHLESS II INTERMITTENT CATHETER
    MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
    ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
    STERILE URETHRAL CATHETER PROCEDURE KITS
    LAKE MALE EXTERNAL CATHETERIZATION KIT
    CATHETER CARE TRAY
    URETHRAL CATHETER TRAY (LATEX)
    FOLEY CATHETER INSERTION TRAY (30CC)
    FOLEY CATHETER INSERTION TRAY (10CC)
    URETHRAL CATHETER TRAY (PVC)
    URETHRAL CATHETERIZATION TRAYS
    FOLEY CATHETERIZATION TRAY
    TRAY AND BAG, CATHETERIZATION
    TRAY, URETHRAL CATHETERIZATION
    URETHRO CATHETERIZATION TRAY
    URINARY CATHETER CARE SET
    BLADDER RETENTION-CATHETHERIZATIONTRAY
    CATHETERIZATION KIT 732016-732018
    BLADDER CATH KIT W/OUT CATHETER
    ROBINSON KIT - 750014 & 750016
    BLADDER KIT - 734000
    CATHETERIZATION PROCED. TRAY, URETHRAL
    CATHETERIZATION PROCEDURE TRAY

    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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