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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: LRJ FDA class 1

    Disinfectant, Medical Devices

    General Hospital

    View full classification →

    Medical device disinfectants are chemical agents specifically formulated and intended for the cleaning and disinfection of reusable medical devices, reducing microbial contamination to safe levels between patient uses. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRJ, regulated under 21 CFR 880.6890, within the General Hospital medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CONTROL III ELITE
    PRO-PORTION CLEANER/DISINFECTANT
    MICROSTAT 2
    AMERSE 2
    DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
    LOW PH PHENOLIC 256
    CITREX HOSPITAL SPRAY DISINFECTANT
    KLEENASEPTIC
    T.B.Q. RTU
    GERMICIDAL CLOTH
    NOVIGUARD QUICK DRY
    BLUE CHIP GERMICIDAL CLEANER & DEODORANT
    CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
    VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
    COVERAGE SPRAY HBV
    COVERAGE HBV
    VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
    TRIAD II DISINFECTANT CLEANER AND DEODORANT
    VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
    LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
    T.B.Q.
    DMS-9000
    ASCEND GENERAL PURPOSE DISINFECTANT
    MATAR GENERAL PURPOSE DISINFECTANT
    BEAUCOUP GENERAL PURPOSE DISINFECTANT
    PRO-TECH
    KLORMAN
    VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
    BIOCIDE CLEANER/DISINFECTANT
    LD GENERAL PURPOSE DISINFECTANT
    EXSPOR
    Q5. 5-5.5NPB-2.5HW
    TRI-CEN GERMICIDAL DETERGENT
    CITRACE HOSPITAL GERMICIDAL DEODORIZER
    DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
    FORMULATION HWS-128 EPA REG. NO. 47371-130
    FORMULATION HWS-64 EPA REG. NO. 47371-131
    FORMULATION HWS-256 EPA REG. NO. 47371-129
    PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
    AMUCHINA
    PHENO-CEN GERMICIDAL DETERGENT
    RENALIN COLD STERILANT
    IMNI-II
    CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
    Q4.5-5.0PB-4.5
    PHENO-CEN SPRAY DISINFECTANT DEODORANT
    LYSOL I.C. BRAND DISINFECTANT
    HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT
    OCIDE HOSPITAL CLEANER-DISINFECTANT
    MULTI-WASH

    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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