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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: CAH FDA class 2

    Filter, Bacterial, Breathing-Circuit

    Anesthesiology

    View full classification →

    The Breathing-Circuit Bacterial Filter is a device placed in-line with an anesthesia or ventilation breathing circuit to prevent the transmission of microorganisms between the patient and the circuit, protecting both the patient and equipment from contamination. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAH, regulated under 21 CFR 868.5260, within the Anesthesiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Besmed Bacterial Filter and HMEF
    Breathing circuit bacterial/viral filter
    Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
    TNI Clear-Guard™ 3 angled breathing filter (1545020)
    Filter and HME/Filter
    Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
    EasyOne Filter
    GGM Breathing Circuit Bacterial Filter
    Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
    Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
    HepaShield Bacterial Viral Breathing System Filter
    Altera Filter and HME/Filter
    Servo Guard
    SafeBreath Filter Mouthpiece
    ThermoShield HME Filter
    Breathing circuit bacterial/viral filter
    INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
    VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
    AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
    EXCELERON BACTERIAL FILTERS
    RT016 INSPIRATORY FILTER
    HYRDROMAX HMEF
    WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
    FLO-GUARD BREATHING FILTER
    HUMID-VENT HEPA
    MEDISIZE RED AND MEDISIZE BLUE
    MICROGARD II
    SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
    INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
    FIL 1520
    HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
    BACT-TRAP HEPA MIDI
    COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
    FLEXICARE BREATHING FILTERS
    THERMOFLO HCH, THERMOFLO FILTER
    70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
    MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
    FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
    A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
    FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
    OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
    BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
    RT019 INSPIRATORY/EXPIRATORY FILTER
    AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
    MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
    ALL FLOW PULMONARY FUNCTION FILTER
    KUNG SHIN, HMEF SK203
    AIR SAFETY HEPA AND NON-HEPA FILTERS
    CLEAR-THERM MICRO HME, MODEL 1441
    SERVO GUARD, MODEL 64 81 290 EH88E

    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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