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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: EZD FDA class 2

    Catheter, Straight

    Gastroenterology, Urology

    View full classification →

    The Straight Catheter (product code EZD) is a basic urinary catheter with a straight tip used to drain urine from the bladder or to instill fluids. It is an FDA Class 2 device (moderate risk), requiring 510(k) clearance before marketing. 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 Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
    Luja Coudé
    Luja Set
    SureCath Set
    Luja Coude
    Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
    Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
    GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
    Cure Catheter Closed System; Cure Dextra Closed System
    Luja Coude (20108 Male CH18 - large packaging)
    Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
    PVC Hydrophilic Urethral Catheter
    SimPro™ Now, GentleCath™ Hydrophilic
    Intermittent nelaton catheter for single use
    Sleeved IC
    PVC Hydrophilic Urethral Catheter
    Self-Cath and Self-Cath Plus
    Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
    SpeediCath Flex Set
    Female IC (Not Finalized)
    BONREE Nelaton Catheter
    SpeedCath Compact Male
    SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
    LoFric Elle
    Wiygul Catheter
    AMSure Hydrophilic Intermittent Catheter
    COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
    Medline Catheter Specimen Collector
    Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
    Magic3 Go Intermittent Urinary Catheter
    PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
    CompactCath Intermittent Urinary Catheter
    FULL CARE Disposable PVC Nelaton Catheter
    Magic3 Go Intermittent Urinary Catheter
    Bard RiteCath Intermittent Urinary Catheter
    Well Lead PVC Urethral Catheter
    COMPACTCATH INTERMITTENT URINARY CATHETER
    BARD RITECATH INTERMITTENT CATHETER
    WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
    CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
    CLASSIC INTERMITTENT CATHETER
    HYDROSIL; MAGIC; PERSONAL CATHETER
    LOFRIC SENSE
    LOFRIC PRIMO, LOFRIC HYDRO-KIT
    LOFRIC SINGLE USE URINARY CATHETER
    COMFORTGLIDE INTERMITENT CATHETER
    CURE CATHETER
    DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
    COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
    MEDLINE PVC URETHRAL 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.

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