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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: FMZ FDA class 2

    Incubator, Neonatal

    General Hospital

    View full classification →

    The Neonatal Incubator is a device that provides a controlled, enclosed environment for premature or ill newborns, regulating temperature, humidity, and oxygen levels to support physiological stability during intensive care. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMZ, regulated under 21 CFR 880.5400 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Giraffe Incubator Carestation CS1
    Infant Incubator
    Babyleo TN500
    Isolette 8000 Plus
    Isolette 8000 plus
    Babyleo TN500
    Giraffe OmniBed Carestation CS1
    Giraffe Incubator Carestation CS1
    INFANT INCUBATOR
    DUAL INCU I
    INCU I
    NEO-SERVO I
    GIRAFFE OMNIBED
    GIRAFFE INCUBATOR
    TARRY MEDICAL TEMPERATURE PROBES
    MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
    MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
    OHMEDA MEDICAL GIRAFFE OMNIBED
    V-2200 INFANT INCUBATOR
    VERSALET 7700 CARE CENTER
    V-2200 INFANT INCUBATOR
    INFANT INCUBATOR, MODEL CHS-I1000
    BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
    ISOLETTE INFANT INCUBATOR, MODEL C2000E
    V-2100G ADVANCED INFANT INCUBATOR
    OHMEDA MEDICAL GIRAFFE OMNIBED
    OHMEDA MEDICAL GIRAFFE INCUBATOR
    OHMEDA MEDICAL GIRAFFE INCUBATOR
    CALEO
    ISOLETTE INFANT INCUBATOR, MODEL C2HS
    VERSALET 7700 CARE CENTER, MODEL # 7700
    OHMEDA MEDICAL OMNIBED
    BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
    BABYTHERM 8000 LDR
    OHMEDA-OHIO CARE PLUS INCUBATOR
    DRAGER INCUBATOR 8000 IC
    OHMEDA-OHIO CAE PLUS INCUBATOR
    ISOLETTE INFANT INCUBATOR
    OHIO CARE PLUS INCUBATOR
    C450/C400 INFANT INCUBATORS
    K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
    BOWRON
    MEDIX PC-305 NEONATAL INCUBATOR
    DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER
    ISOLETTE INCUBATOR HUMIDITY METER
    TYPE INTERFACE 9271/1 INCUBATOR/WARMER
    FIRST TOUCH/VILEDON NON-WOVEN FILTER
    MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR
    OHIO CARE PLUS INCUBATOR
    INCUBATOR 8000 IC

    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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