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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: CBT FDA class 1

    Arterial Blood Sampling Kit

    Anesthesiology

    View full classification →

    The Arterial Blood Sampling Kit is a convenience kit used in anesthesiology containing the components needed to collect arterial blood samples for blood gas analysis, typically including a syringe, needle, and related accessories. Per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in that guidance. It is classified as FDA Class 1 (lowest risk). The product code is CBT, regulated under 21 CFR 868.1100, within the Anesthesiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
    SECURE ARTERIAL BLOOD SAMPLING SYSTEM
    ABC IN-LINE BLOOD SAMPLING KIT
    ABG POINT LOK NEEDLE PROTECTION DEVICE
    ACTI-FLEX ARTERIAL EXTENSION SET
    NEEDLE SAFETY COVER
    ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
    PISTON SYRINGE
    ABG NEEDLE PROTECTION
    ASPIR-PULSE(TM) SAF-T-VENT
    VACVENT
    BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
    SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
    DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
    SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
    NEOLINE(TM)
    ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
    MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
    LAB-SITE SAFETY NEEDLE
    GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
    UMBILICAL CORD BLOOD SAMPLING KIT
    MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
    BLOOD GAS SAFETY SYRINGE
    CIBA CORNING BALANCED HEPARIN FOR CA++
    CORD-ASSURE UMBILICAL BLOOD GAS KIT
    AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
    BIOSAMPLER
    ARTAP ARTERIAL BLOOD SAMPLING DEVICE
    MARQUEST MICRO STIK 9000 SERIES
    ARTERIAL BLOOD SAMPLING KITS
    PREFILLED PULSATOR SYRINGE
    VAPORIZED HEPARIN
    MARZ-175 ARTERIAL BLOOD GAS SYRINGE
    PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
    ARTERIAL BLOOD SAMPLING KIT
    AUTO STIK
    ASPIRATOR
    OMNISTICK
    QUALISTICK ARTERIAL BLOOD SAMPLER
    ABG KITS - CMS 4000 SERIES
    DESERET ARTERIAL BLOOD SAMPLING KIT
    MDM ARTERIAL BLOOD GAS KIT
    ARTERIAL BLOOD SAMPLING KIT
    AUTOSTIK
    PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
    EASY-FLO ARTERIAL BLOOD GAS KIT
    MARZ-175
    ASPIRATOR
    ORGANON ARTERIAL BLOOD SAMPLER
    SAMPLING KIT

    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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