BEUDAMED
    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: EXB FDA class 1

    Collector, Ostomy

    Gastroenterology, Urology

    View full classification →

    The ostomy collector is a pouching or collecting system worn over a surgically created stoma to collect intestinal or urinary output following procedures such as colostomy, ileostomy, or urostomy. It is classified as FDA Class 1, indicating minimal risk, subject only to general controls. The product code is EXB, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SmartBag (SmartPouch)
    OSTOM-I ALERT
    LAKE OSTOMY CARE SET
    ODOR-END EMERGENCY CLEAN UP POWDER
    CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
    EMERGENCY-CLEAN UP(TM) ECP
    COMBINATION NITE DRAINAGE UNIT
    'CATCH-IT' OR FECAL CONTAINMENT DEVICE
    ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
    OSTO-PURE
    PALEX (R) OSTOMY
    E-Z LOOP
    EZ TAC FILTER
    PERSONAL PUNCH
    ULTRA-GEL - #4083
    BARD IRYFIX(TM) STOMA CAP
    COLOPLAST CONVEX RING
    DURAHESIVE PROTECTIVE BARRIER WIPE
    MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
    DURAHESIVE WAFER WITH FLANGE
    CONFIDENT ODOR ELIMINATOR
    OSTOMY BAGS URETHEROSTOMY
    OSTOMY BAGS COLOSTOMY
    OSTOMY BAGS ILEOSTOMY
    STOMAHESIVE SKIN BARRIER STERILE
    JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
    DISPOSABLE UROSTOMY POUCH
    BARD PERISTOMAL PASTE
    DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY
    UNITED SKIN BARRIERS
    COLOPLAST URO 2002 UROSTOMY SYSTEM
    JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
    UNITED SKIN BARRIERS
    SUR-FIT IRRIGATION ADAPTER FACEPLATE
    OSTOMY OR UROSTOMY ABDOMINAL BELT OS
    OSTOMY FREEDOM KIT
    SWEEN-A-PEEL PERISTOMAL WAFERS
    ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
    ACTIVE LIFE ONE-PIECE STOMA CAP
    COMFEEL PROTECTIVE FILM
    BANGORT LIFESTYLE COLOSTOMY POUCHES
    MC 2002 OSTOMY POUCHES & SKIN FLANGES
    MC 2000 OSTOMY POUCHES
    FILTRODER FILTERS
    SUR-FIT UROSTOMY POUCH W/ACCUSEAL
    BARD KARAYA GUM WASHERS
    STERILE DRAINAGE SYSTEM
    COMFEEL PASTE
    COMFEEL BARRIER CREAM
    COMFEEL CLEANSER

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump