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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: CAW FDA class 2

    Generator, Oxygen, Portable

    Anesthesiology

    View full classification →

    The Portable Oxygen Generator is an anesthesiology device designed to produce oxygen on-demand for use in portable or emergency settings, supplying supplemental oxygen to patients who cannot access traditional compressed gas cylinders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAW, regulated under 21 CFR 868.5440, within the Anesthesiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Portable Oxygen Concentrator
    Oxygen Concentrator (OX-5A, OX-5C)
    OxyGo Portable Oxygen Concentrator (1400-7000)
    DeVilbiss 5 Liter Oxygen Concentrator (555)
    Oxygen Concentrator (J10A)
    Oxygen Concentrator-P2-O5E
    Portable oxygen concentrator (JLO-190P)
    V series portable oxygen concentrator (V5, V5C, V6, V6C)
    DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
    Oxygen Concentrator (J5A)
    Portable oxygen concentrator (JAY-1000P)
    Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
    Portable Oxygen Concentrator (JM-P50A)
    FreeStyle Comfort (AS200 / FreeStyle Comfort)
    Portable Oxygen Concentrator (Spirit-3)
    Portable Oxygen Concentrator (P2-TOC)
    Oxygen Concentrator (ZY-10AB/115)
    Rugged Oxygen Generator (ROG) (RO01-00001)
    Oxygen Concentrator
    Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
    Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
    Oxygen concentrator
    Inogen Rove 6
    Portable Oxygen Concentrator (Model: P2-E7, P2-E)
    Oxus Sieve Beds
    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
    Inogen Rove 4 Portable Oxygen Concentrator
    Oxygen Concentrator, Model JAY-5AW
    Portable Oxygen Concentrator, model: P2-E6
    Oxygen Concentrator
    Invacare Platinum 5NXG Oxygen Concentrator
    X-PLO2R
    Invacare Perfecto2V Oxygen Concentrator
    Aer X
    Owgels Oxygen Concentrator
    Nuvo Nano Portable Oxygen Concentrator
    Kingon P2 Oxygen Concentrator
    Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
    CONTEC Oxygen Concentrator
    O2 Concepts Oxlife Independence Model 301-0001
    Oxygen Concentrator
    Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
    GCE Zen-O Portable Oxygen Concentrator
    Invacare Platinum Mobile Oxygen Concentrator
    Deployable Oxygen Generation System-Smaill (DOGS-S)
    PUREFILL OXYGEN COMPRESSOR
    LONGFIAN OXYGEN CONCENTRATOR
    INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
    ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
    2300 SERIES MGO PORTABLE OXYGEN

    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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