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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: FLE FDA class 2

    Sterilizer, Steam

    General Hospital

    View full classification →

    The Steam Sterilizer is a hospital device that uses pressurized saturated steam to sterilize medical instruments and equipment, eliminating microorganisms to prevent infection. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLE, regulated under 21 CFR 880.6880 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Steam Sterilizer (2545D)
    FRONT-LINE Field Sterilizer (FL135)
    Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
    Lexa MINI (RIS-303, RIS-305)
    PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
    T-Top 10 & T-Top T-Top 11
    AMSCO 600 Steam Sterilizer
    Sturdy Autoclave Super Microm
    Lexa MINI (RIS-303, RIS-305)
    PRIMUS Healthcare Sterilizer (Model PSS11-HC)
    Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
    Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
    MOST-T Autoclave
    Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
    Lexa PLUS RIS-311
    Consolidated HC Steam Sterilizer
    GSS610N21 Series Steam Sterilizer
    STATIM 6000B Vacuum Autoclave
    Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
    Enbio S
    T-Edge 10, T-Edge 11
    Enbio S
    AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
    AMSCO 600 Medium Steam Sterilizer
    Bravo G4 Chamber Autoclave
    Getinge GSS610N Series Steam Sterilizer
    Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)
    STATClave G4 Chamber Autoclave
    STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
    Belimed Steam Sterilizer MST-H TOP 5000
    STATCLAVE G4 Chamber Autoclave
    Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
    AMSCO 600 Steam Sterilizer
    Saniclave 250
    MN-111
    Amsco Evolution Medium Steam Sterilizer
    Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
    Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
    Amsco Evolution Medium Steam Sterilizer
    Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
    Getinge GSS67N Series Steam Sterilizer
    Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
    Belimed Steam Sterilizer MST-H TOP 5000
    Family of Steam sterilizers B17 B22 Series
    Family of Steam Sterilizers B 28 series
    BELIMED STEAM STERILIZER MST-H
    STERISAFE HP TABLE-TOP STEAM STERILIZER
    Pre-vacuum Tabletop Autoclave
    FORT DEFIANCE AUTOMATED STEAM STERILIZER
    SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER

    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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