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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: CAD FDA class 2

    Vaporizer, Anesthesia, Non-Heated

    Anesthesiology

    View full classification →

    The Non-Heated Anesthesia Vaporizer is a device used in anesthesiology to deliver precise concentrations of volatile anesthetic agents to patients during surgical procedures, without the use of a heating element. It is classified as FDA Class 2 (moderate risk), meaning it requires 510(k) premarket notification before marketing, demonstrating substantial equivalence to a legally marketed predicate device. The product code is CAD, regulated under 21 CFR 868.5880, within the Anesthesiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    V80 Anesthetic Vaporizer (V80)
    Tec 820, Tec 850
    V60 Anesthetic Vaporizer
    SEVOFLURANE VAPORIZER ADAPTOR
    SIGMA ALPHA VAPORIZER
    KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
    GAV - GENERAL ANAESTHETIC VAPORIZER
    D-VAPOR
    DELTA T
    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
    SIGMA DELTA
    DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
    DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
    DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
    VAPAMASTA 6
    SIEMENS SEVOFLURANE VAPORIZER SV 953
    DRAGER-VAPOR 19.3
    DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
    DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
    DRAGER-VAPOR 2000
    TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
    QUIK-FIL VAPORIZER KEYED FILLER
    PPV VAPORIZER (MODIFICATION)
    TECHFIL
    TECHNOFIL
    DATUM
    OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
    VAPOFIL
    SIGMA ELITE
    DRAGER-VAPOR 19.1
    SIGMA ELITE
    FUNNEL ADAPTOR
    OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
    OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
    VAPAMASTA 5
    LUNDY VAPORIZER SYSTEM
    VAPORIZER, ANESTHESIA, NON-HEATED
    KEYFILL
    VAPLOK
    VAPOFIL
    VAPORIZER SPACER
    ANESTHESIA VENTILATOR MODEL 100
    PENLON PPV VAPORIZER
    ANAESLOCK THREE VAPORIZER INTERLOCK HVA003
    HALOTHANE VAPORIZER 950, ENFLURANE
    CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
    MODULUS VERNI-TROL ANESTHETIC VAPORIZER
    DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
    MODULUS VERNI-TROL ANESTHETIC VAPORIZER

    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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