BEUDAMED
    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: JOJ FDA class 2

    Indicator, Physical/Chemical Sterilization Process

    General Hospital

    View full classification →

    The Indicator, Physical/Chemical Sterilization Process is a general hospital device used to monitor and verify the effectiveness of physical or chemical sterilization processes, providing a visible or measurable change to indicate that sterilization conditions have been achieved for medical instruments and equipment. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code JOJ and is regulated under 21 CFR 880.2800, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DISINTEK™ PA Test Strips
    Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
    VERIFY STEAM Integrating Indicator
    Green Card Bowie-Dick Test (BD115)
    Type 5 Integrating Indicator for Steam (CSPN-15)
    Autoclave Indicator Tape; EO Indicator Tape
    Chemical Indicator for enspire CLCSPS (LCC015)
    Getinge Assured MI Steam Migrating Integrator
    Kem Medical Lead-free Chemical Indicators for Steam Sterilization
    CELERITY HP Indicator Tape (PCC077)
    STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)
    Ultraphon Chemical Indicator (TRO-T and TRO-B)
    EO Chex Indicator Tape
    MetriCide™ OPA Plus Solution Test Strip
    3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
    Celerity Chemical Indicator for enspire 3000 CLCSPS
    CELERITY HP Indicator Tape
    VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
    Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
    Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
    Revital-Ox PAA High Level Disinfectant Chemical Indicator
    OK Plus Indicator
    Chemical Indicator for Steam
    3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
    3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
    3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
    3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
    VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
    Gas-Chex Indicator
    3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
    Crosstex VH2O2 Chemical Indicators
    Steri-Dot Process Indicator
    Steam-Dot Process Indicator
    3M Comply Hydrogen Peroxide Chemical Indicator 1248
    3M Comply Hydrogen Peroxide Indicator Tape 1228
    WAVICIDE-OPA MEC Indicator
    AN1036 Dosimeter
    Terragene Chemdye
    Getinge Assured MI Steam Migrating Integrator
    QwikCheck Chemical Indicators
    3M Attest Steam Chemical Integrator
    3M™ Attest™ Steam Chemical Integrators
    3M Comply Hydrogen Peroxide Chemical Indicator
    3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
    Sterilucent VH2O2 Chemical Indicators
    Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
    Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
    Lead-free Chemical Indicators for Steam Sterilization
    3M Comply Hydrogen Peroxide Chemical Indicator
    3M Comply Hydrogen Peroxide Indicator Tape

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump