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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: HRX FDA class 2

    Arthroscope

    Orthopedic

    View full classification →

    An arthroscope is a rigid or flexible endoscopic device inserted into a joint cavity to allow direct visual examination and surgical intervention within joints such as the knee, shoulder, or hip. It is classified as an FDA Class 2 device under 21 CFR 888.1100, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRX falls under the Orthopedic medical specialty. Per FDA guidance, if the arthroscope is reusable and has specific design features requiring validated reprocessing, reprocessing validation data must be included in any 510(k) submission (refer to 82 FR 26807, June 9, 2017). This device is eligible for third party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Arthrex Spine Endoscope
    VECTR – Video Endoscopic Carpal Tunnel Release System
    MIDASVu
    Vertos mild Device Kit (MDK-0002)
    Digital ClarusScope System; Digital NeuroPEN System
    FMS VUE™ Fluid Management and Tissue Debridement System
    Hawkeye Control Unit with Eyas Endoscope
    Kyphoplasty Balloon Catheter
    Kyphoplasty Balloon System
    DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
    SmartRelease Endoscopic Soft Tissue Release System
    Pristine Arthroscopic Visualization System
    HBL Blade Assembly
    TELIGEN System
    CORUS Spinal System-X
    mi-eye 3 needlescope with cannula, mi-tablet 3
    SMARTRELEASE Endoscopic Soft Tissue Release System
    DOUBLEFLO system
    Balex bone Expander System
    EBERLE Shaver System C3 and Accessories
    C Scope Visualization System
    Resascope RS-01/B
    Stryker Arthroscope
    Zeos Aqua Vision Pump and tube
    MectaScope System
    Osteo-site Vertebral Balloon
    Smith+Nephew Arthroscopes
    HydroCision SpineJet System
    Arcadia Balloon Catheter
    Smith & Nephew DYONICS 25 Fluid Management System
    Pegasus System
    Stryker CrossFlow Integrated Arthroscopy Pump
    Nuvis Battery Arthroscope
    Voyant System
    HydroCision TenJet Device
    MEDINAUT Plus
    CROSSWAY Spinal Access System
    CORUS Spinal System
    Pristine Scope
    Precision Ideal Eyes Arthroscopes
    Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
    CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
    SMARTRELEASE Endoscopic Soft Tissue Release System
    Voyant System
    MIDAScope and Introducer Kit, and MIDASystem
    Endiscope, Endiscope Cervical
    Single Use Arthroscopic Electrode (with Pencil)
    DTRAX Spinal System
    ARTHRO-Pump PA304
    DISKOM

    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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