BEUDAMED
    Product Code: MLR FDA class 2 21 CFR 880.6860

    Sterilizer, Chemical

    General Hospital

    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.

    View on FDA
    510(k)s
    47
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    11
    Years Active
    32

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    Basic Information

    Product Code
    MLR
    Device Class
    FDA class 2
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 47 510(k) clearances via K numbers.

    K Number Device Name
    K252843 STERRAD 100NX Sterilization System with ALLClear Technology (10104)
    K250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
    K231893 LOWTEM Crystal 120
    K234082 STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)
    K233762 SteroScope® Sterilization Technology System
    K233065 V-PRO maX 2 Low Temperature Sterilization System
    K223476 V-PRO maX 2 Low Temperature Sterilization System
    K231169 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)
    K223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
    K220345 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)
    K222093 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
    K220404 STERRAD NX with ALLClear Technology
    K212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
    K212174 STERRAD 100NX Sterilizer with ALLClear Technology
    K190005 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
    K190917 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
    K190103 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
    K182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
    K172754 V-PRO maX 2 Low Temperature Sterilization System
    K172319 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
    K162413 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
    K162007 STERRAD NX Sterilizer
    K160818 STERRAD® NX Sterilizer with ALLClear™ Technology
    K160903 STERRAD 100NX Sterilizer with ALLClearTM Technology
    K160433 V-PRO® 1 Plus and V-PRO® maX Low Temperature
    K151725 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    K142454 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
    K140464 STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
    K140498 V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
    K131120 AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    K111377 STERRAD(R) 100NX STERILIZER DUO CYCLE
    K120632 AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
    K112813 AMSCO V-PRO
    K112760 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    K111810 AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
    K102394 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
    K102330 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
    K092622 STERRAD 100NX STERILIZER EXPRESS CYCLE
    K083097 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
    K071385 STERRAD 100NX STERILIZER
    K062297 VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
    K042116 STERRAD NX STERILIZER
    K030429 STERRAD 200 STERILIZER
    K991999 STERRAD 100S STERILIZER
    K981625 STERRAD 50 STERILIZER
    K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    K924380 MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.