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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: JAQ FDA class 2

    System, Applicator, Radionuclide, Remote-Controlled

    Radiology

    View full classification →

    A remote-controlled radionuclide applicator system is used in brachytherapy to mechanically deliver and retract radioactive sources to and from treatment positions within or adjacent to tumors, protecting staff from radiation exposure during the loading and unloading process. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JAQ, regulated under 21 CFR 892.5700, within the Radiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CT/ MR Tandem and Ovoid Set
    Intracavitary/Interstitial System
    Titanium Flexible Geometry FSD Applicator Set (GM11013400)
    Mould Probe MR Safe
    Intraluminal Applicator Set
    “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
    Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
    Catheter Surface Flap Applicator Set (GM11011830)
    Heyman Packing Applicator Set (GM11004580)
    AOS Interstitial Templates, Needles, and Accessories
    AOS Marker Seeds (SMG0242-025)
    Flexible Fixation Device for Gynecological Applicators (GM11001960)
    Universal Endometrial Applicator Set (GM11009840)
    Kelowna GYN and Crook Prostate Templates
    Mick Valencia Applicator Set
    Aarhus Applicator Set
    BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
    Universal Cylinder Applicator Family
    Geneva
    ASSISTO Universal Applicator Clamping Device
    CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
    BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
    “BRAXX” Esophageal Brachytherapy Applicator
    GM Implant Tubes, Length Cutting Gauge
    BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
    Varian Cervical Sleeves
    HDR MRI Lumen Marker
    Best Instruminal Applicator
    Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
    Standard Catheter Set
    Kelowna GYN and Crook Prostate Templates
    System, Applicator, Radionuclide, Remote Controlled
    Mould Applicator Set
    Interstitial Needles
    Surface Applicator Set
    Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
    Advanced Gynecological Applicator
    Heyman Packing Applicator Set
    Advanced Breast Template System
    Esophagus Bougie Set
    Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
    CT/MR Compatible M.A.C. Interstitial GYN Template
    Varian Sterilization Boxes
    Intraluminal Applicator Set
    Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
    Shielded Applicator Set, Cervical Stop
    3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
    Henschke Titanium Applicator Set
    E-App
    SagiNova

    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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