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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: CAK FDA class 2

    Microfilter, Blood Transfusion

    General Hospital

    View full classification →

    The Blood Transfusion Microfilter is a general hospital device used to remove particulate matter, microaggregates, and debris from blood products during transfusion, reducing the risk of transfusion-related complications. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAK, regulated under 21 CFR 880.5440, within the General Hospital medical specialty. No special flags apply to this device.

    510(k) Clearances

    36 matches
    K Number
    Device Name
    HAEMONETICS 40U RBC FILTER BAG
    SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
    NEOCARE 20 MICRON BLOOD FILTER
    CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
    FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
    FENWAL 40 MICRON TRANSFUSION FILTER
    ALPHA MICRON 20/40 MICROAGGREGATE FILTER
    PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
    ALPHA MICRON 20 MICROAGGREGATE FILTER
    SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
    SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
    MODIFIED SEPACELL R-SERIES BLOOD FILTERS
    SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
    MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
    MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
    MICROSEPT 60/20
    SEPACELL R-500 AND SEPACELL R-500A
    PALL LEUKOCYTE REMOVAL FILTER, BLOOD
    PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
    RESUBMITTED MICRON TRANSFUSION FILTER
    ERYPUR B
    SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
    SEPACELL R-500 & SEPACELL R-500A
    INTERFACE TRANSFUSION BLOOD FILTER #35
    20 MICRON HIGH CAPACITY TRANS/FILTER
    HEMA - NV TRANS. BLOOD FILTER 100/800
    INTERFACE TRANSFUSION BLOOD FILTER #30
    PEDIATRIC MICROAGGREGATE BLOOD FILTER
    HEMA 20 MICRON TRANSFUSION BLOOD FILTER
    ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
    ALPHA MICRON-40 FILTER
    INTERFACE 20 MICRON TRANSFUSION BLD. F.
    BLOOD FILTER, MICROEMBOLI-ATS-F10
    MICROFILTRATION SET MF10
    FILTER, INFUSION BLOOD (1 PFF-100)
    FILTER, TRANSFUSION BLOOD, INTERSEPT

    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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