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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: MED FDA class 2

    Sterilant, Medical Devices

    General Hospital

    View full classification →

    The medical device sterilant is a general hospital chemical agent or system used to achieve sterilization of heat-sensitive reusable medical instruments and equipment, destroying all forms of microbial life including bacterial spores. It is classified as FDA Class II under 21 CFR 880.6885 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MED and the device is not implanted. Full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
    SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
    SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
    SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
    SYSTEM 1E Liquid Chemical Sterilant Processing System
    System 1 endo Liquid Chemical Sterilant Processing System
    SYSTEM 1E Liquid Chemical Sterilant Processing System
    SYSTEM 1E Liquid Chemical Sterilant Processing System
    OPA 30 SOLUTION
    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
    RAPICIDE OPA-28
    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
    ALDAHOL V HIGH LEVEL DISINFECTANT
    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
    SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
    MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
    SYSTEM 1.5 STERILE PROCESSING SYSTEM
    EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
    ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
    RESERT XL HLD HIGH LEVEL DISINFECTANT
    OPACIDEN SOLUTION
    STERILOX LIQUID CHEMICAL STERILANT SYSTEM
    POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
    CIDEX ACTIVATED DIALDEHYDE SOLUTION
    ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
    ALDAHOL III HIGH-LEVEL DISINFECTANT
    CIDEX OPA CONCENTRATE
    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
    BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
    0.55% ORTH-PHTHALALDEHYDE SOLUTION
    STERILOX LIQUID CHEMICAL STERILANT SYSTEM
    MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
    CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
    MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
    CIDEX OPA SOLUTION
    CIDEX OPA SOLUTION
    ENDO-SPOR PLUS / HYPROCIDE
    VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
    SPOROX II STERILIZING & DISINFECTING SOLUTION
    SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
    CETYLCIDE-G
    MEDSCI 3% GLUTARALDEHYDE
    PERACIDIN DIALYZER REPROCESSING CONCENTRATE
    VAPOCIDE
    VAPOPHENE

    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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