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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: CBF FDA class 2

    Chamber, Hyperbaric

    Anesthesiology

    View full classification →

    The Hyperbaric Chamber is an anesthesiology device that encloses a patient in an environment of elevated atmospheric pressure, allowing the breathing of pure oxygen or other gas mixtures at above-ambient pressure, used to treat conditions such as decompression sickness, carbon monoxide poisoning, and non-healing wounds. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBF, regulated under 21 CFR 868.5470, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
    Revitalair 430+
    Revitalair 430F
    OxyHeal 4000 Multiplace Hyperbaric Chamber Family
    Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
    SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
    RSI 4200
    O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
    FLEXI-LITE
    SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
    RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
    HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
    SIGMA SERIES HYPERBARIC CHAMBER
    DIVE AND SHALLOW AND GRAND DIVE
    MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
    HYPEROX 101
    OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
    FLEXI-LITE, MODEL FL-V1.2
    MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
    ATA HCM MONOPLACE HYPERBARIC SYSTEM
    MILLENIUM, MODELS 2000, 2001 AND 2002
    MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
    BAY AREA HYPERSCIENCES
    SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
    MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
    PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
    PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
    BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
    OXYGEN TREATMENT HOOD
    OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
    OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
    INFANT OXYGEN TREATMENT HOOD
    BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
    SEA-LONG MEDICAL TREATMENT HOOD
    MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
    MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
    BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
    SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
    HTU3
    TAMPA HYPERBARIC MONOPLACE CHAMBER
    SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
    SANDS SERIES III HYPERBARIC CHAMBER
    SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
    WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
    HYPERBARIC CHAMBER
    GSP1 - GAS SELECTION PANEL
    ODS1 - HOOD DRIVER
    LOUISVILLE LABS OXYGEN HEAD TENT

    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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