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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: GBM FDA class 2

    Catheter, Urethral

    Gastroenterology, Urology

    View full classification →

    The Catheter, Urethral (product code GBM) is a catheter designed for passage through the urethra into the bladder, used to drain urine or facilitate diagnostic or therapeutic procedures in urology. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device is regulated under 21 CFR 876.5130 in the Gastroenterology, Urology specialty (GU). It is eligible for review by an FDA-accredited third-party reviewer.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
    Intermittent Catheter (Not Finalized)
    SpeediCath Compact Set
    SpeediCath Compact Set
    SpeediCath Soft
    Jimushi Sterile Urethral Catheter for single use
    LotusCatheter (Lotus No Balloon Catheter)
    Actreen Hi-Lite Intermittent Urinary Catheters
    VaPro Plus Pocket, VaPro Plus
    Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
    Infyna Chic
    SpeediCath Flex Coude Pro
    Medline Poly-Cath Red Polymer Urethral Catheter
    Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
    SimplCath
    ValPro 2 Plus, VaPro 2 Plus Pocket
    Actreen Hi-Lite Cath, Actreen Hi-Lite Set
    SpeediCath Standard
    GentleCath Glide Intermittent Urinary Catheter
    VaPro 2 Intermittent Catheter
    SpeediCath Flex Coude Pro
    Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
    Onli Intermittent Catheter
    SpeediCath Flex Coude
    United Urologics Intermittent Catheter
    Actreen Mini Intermittent Urinary Catheters
    VAPRO PLUS POCKET Intermittent Catheter
    SpeediCath Compact Eve
    ThinkMed Intermittent Catheter with/without Hydrophilic Coating
    Speedicath Compact Male
    VaPro Pocket
    VAPRO INTERMITTENT CATHETER
    SPEEDICATH COMPACT SET (12 FR)
    SPEEDICATH COMPACT SET (12/18 FR)
    BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
    VAPRO PLUS INTERMITTENT CATHETER
    HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
    VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
    SPEEDICATH COMPACT
    GUARDIANCATHETER-URINARY DRAINAGE CATHETER
    PEDIATRIC URINARY CATHETER
    ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
    LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
    URINARY CATHETERS
    VITALCARE URETHRAL CATHETER
    SPEEDICATH
    RUSCH FLONEIL; FLOCATH INTROGEL
    MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
    UROLOGICAL CATHETER

    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.

    Popular Product Codes

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