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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: MLR FDA class 2

    Sterilizer, Chemical

    General Hospital

    View full classification →

    The Chemical Sterilizer is a device that uses chemical agents, such as ethylene oxide, hydrogen peroxide vapor, or peracetic acid, to sterilize medical instruments, equipment, or materials in healthcare settings, rendering them free from viable microorganisms. Classified as a Class 2 device under 21 CFR 880.6860 within the General Hospital specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    510(k) Clearances

    46 matches
    K Number
    Device Name
    STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
    LOWTEM Crystal 120
    STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)
    SteroScope® Sterilization Technology System
    V-PRO maX 2 Low Temperature Sterilization System
    V-PRO maX 2 Low Temperature Sterilization System
    STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
    STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
    STERRAD NX with ALLClear Technology
    STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
    STERRAD 100NX Sterilizer with ALLClear Technology
    Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
    V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
    V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
    V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
    V-PRO maX 2 Low Temperature Sterilization System
    AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
    AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
    STERRAD NX Sterilizer
    STERRAD® NX Sterilizer with ALLClear™ Technology
    STERRAD 100NX Sterilizer with ALLClearTM Technology
    V-PRO® 1 Plus and V-PRO® maX Low Temperature
    STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
    V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
    AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    STERRAD(R) 100NX STERILIZER DUO CYCLE
    AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
    AMSCO V-PRO
    AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
    AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
    AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    STERRAD 100NX STERILIZER EXPRESS CYCLE
    AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
    STERRAD 100NX STERILIZER
    VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
    STERRAD NX STERILIZER
    STERRAD 200 STERILIZER
    STERRAD 100S STERILIZER
    STERRAD 50 STERILIZER
    HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE

    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

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