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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: OCX FDA class 2

    Endoscopic Irrigation/Suction System

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Irrigation/Suction System (product code OCX) is a gastroenterology and urology device used to supply sterile water or other solutions to endoscopes and to apply suction during endoscopic procedures, maintaining a clear operative field and flushing debris or blood from the working area. These functions are essential for visibility and safety during endoscopy. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ArgoCap (200.52)
    Endoscopic Water Pump
    Water Container (MAJ-901); Water Container (MAJ-902)
    Aspiration Catheter (2189)
    ClearCap Distal Attachment
    troCarWash™ System
    Endoscopy Irrigation Tubing
    Air/Water Bottle Tubing, CO2 Source Tubing
    ENDOGATOR™ Hybrid Irrigation Tubing
    Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
    ANDORATE® Valve Kit
    Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
    troCarWash™ System
    AquaPulse® Irrigation Tubing
    Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
    Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
    Clean Connecting Tube
    OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
    Erbe's Tubing/Cap Sets
    Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
    ENDOtube
    ClearCap Distal Attachment
    AquaPulse Irrigation Tubing
    AquaPulse Auxiliary Water Connector
    Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
    Irrigation Tubing with CO2 or Air
    C2 CryoBalloon EndoGrip
    Vacutore Air/Water Bottle Tubing
    ScopeFlow Pure(TM)
    EndoStream(TM)
    ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
    ERBEFLO 2 Disposable Tubing System
    Andorate Auxiliary Water Connector
    Glo-Tip Spray Catheter
    ERBEFLO Olympus Scope Port Connector
    Seal Single Use Biopsy Valve
    Endorate Valve Sets
    Disposable Biopsy Valve
    OpClear System
    Seal Single-Use Biopsy Valve
    ENDOFLOW II - Irrigation, Warming and Suction System
    Boa Endoscopic Valve
    BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
    Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
    ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
    US ENDOSCOPY DISTAL ATTACHMENT CAP
    SEAL SINGLE-USE BIOPSY VALVE
    TORRENT IRRIGATION SYSTEM
    MEDLINE BIOPSY VALVE
    SEAL BIOPSY VALVE - REUSABLE

    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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