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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: KRB FDA class 2

    Probe, Thermodilution

    Cardiovascular

    View full classification →

    This device is a thermodilution probe used in conjunction with a pulmonary artery catheter to measure cardiac output by detecting temperature changes in blood following injection of a cold bolus, providing hemodynamic data critical to intensive care management. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRB, regulated under 21 CFR 870.1915 within the Cardiovascular specialty. This device is eligible for third-party review.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    PiCCO Catheter
    VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
    PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
    CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
    PACEVIEW
    SAFEWEDGE(TM) RELIEF VALVE DEVICE
    INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
    INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
    PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
    CCO SYSTEM MODEL SP1467,SP5567,SP6267
    THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
    NUMED BALLOON THERMODILUTION CATHETER
    MODIFIED MYOCARDIAL TEMPERATURE SENSOR
    ACKRAD TDI SET
    FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
    FLOW DIRECTED THERMODILUTION CATH W/VEN
    HEPARIN COATED THERMODILUTION CATHETERS
    THERMODILUTION CATHETER
    MIKRO-TIP CATH. PRESSURE TRANSDUCER
    MON-A-THERM MYOCARDIAL TEMP. SENSOR
    FLOW-DIRECTED THERMODILUTION CATHETER
    MODEL SP 5507 5-LUMEN THERMODILUTION CAT
    SWAN-GANZ HEPARIN COATED, ETC. CATHETER
    THERMODILUTION KIT
    EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
    MODEL SP5107 THERMODILUTION CATHETER
    BENTLEY THEROMODILUTION CATHETER #BTD-7F
    MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR
    KMA FLOW DIRECTED THERMODILUTION CATHETE
    USCI SAFE-T-CLOTH THERMODILUTION CAT.
    4F STERILE BALLOON-LESS, CATHETER 913-28
    PROBE & CATHETER
    CATHETER, THERMAL DILUTION, ANIMAL & PED
    CATHETER, THERMAL DILUTION, OPEN CHEST
    CATHETER, THERMAL DILUTION, PEDIATRIC

    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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