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: MRC FDA class 2

    Products, Contact Lens Care, Rigid Gas Permeable

    Ophthalmic

    View full classification →

    Rigid Gas Permeable Contact Lens Care Products are ophthalmic devices including solutions, cleaners, conditioners, and enzyme treatments designed for the cleaning, disinfection, rinsing, and storage of rigid gas permeable (RGP) contact lenses. Classified as FDA Class 2 under 21 CFR 886.5918, they require 510(k) premarket notification. The product code is MRC, and they are eligible for third-party 510(k) review.

    510(k) Clearances

    32 matches
    K Number
    Device Name
    Boston One Step Liquid Enzymatic Cleaner
    VibrantVue Scleral Saline
    MaxiTears Contacts PF
    Nutrifill
    Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
    Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
    Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
    Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
    MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
    MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
    MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
    JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
    COMPLETE BLINK-N-CLEAN LENS DROPS
    BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
    MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
    AQUIFY LENS COMFORT DROPS
    MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
    DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
    MENICON PROGENT REMOVER
    LIPIDURE REWETTING DROPS
    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
    OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
    OPTIMUM WETTING AND REWETTING DROP
    SOLO-CARE BRAND HARD SOLUTION
    OPTI-FREE EXPRESS LENS DROPS
    RGP MULTI-PURPOSE SOLUTION ID 100136
    HYLASHIELD CL
    SOLO-CARE BRAND HARD SOLUTION
    RIGID GAS PERMEABLE CONTACT LENS SOLUTION
    SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
    BOSTON ADVANCE CLEANER

    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