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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: CAC FDA class 2

    Apparatus, Autotransfusion

    Anesthesiology

    View full classification →

    The Apparatus, Autotransfusion is a device used to collect, filter, and reinfuse a patient's own blood lost during surgery, reducing the need for allogeneic blood transfusions and their associated risks. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is CAC, regulated under 21 CFR 868.5830 in the Anesthesiology specialty, reviewed by the Cardiovascular panel. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    XTRA Collection sets; XTRA Sequestration set X
    Aventus Clot Management System
    XTRA Autotransfusion System (with XTRA Bowl sets)
    FlowSaver Blood Return System (80-101)
    FlowSaver Blood Return System
    Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
    Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
    Hemafuse System
    FlowSaver Blood Filter
    CATSmart, Automated Blood Processing Autotransfusion System
    ProCell Surgical Sponge-Blood Recovery Unit
    CATSmart
    CATSmart
    autoLog IQ Autotransfusion System
    Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
    CATSmart
    Haemonetics Cell Saver Elite Autotransfusion System
    PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
    PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
    XTRA
    PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
    PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
    ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
    CELL SAVER ELITE
    XTRA
    XVAC
    HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
    PREASSEMBLED SURGICAL WASH SET
    XTRA AUTOTRANSFUSION SYSTEM
    AUTOLOG AUTOTRANSFUSION SYSTEM
    PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
    CYTORI CELUTION CELL CONCENTRATION DEVICE
    HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
    HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
    EXPRESS AND OASIS CHEST DRAIN
    HEMOVAC BLOOD REINFUSION SYSTEM
    S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
    PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
    SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
    SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
    DIDECO ELECTA
    ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
    ACCESS SEQUESTRATION SYSTEM
    AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
    HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
    FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
    HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
    ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
    COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
    SMARTCELL PROCESSING SYSTEM

    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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