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510(k) Data Aggregation

    K Number
    K251619

    Validate with FDA (Live)

    Device Name
    Babyleo TN500
    Date Cleared
    2026-02-13

    (262 days)

    Product Code
    Regulation Number
    880.5400
    Age Range
    0 - 2
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Babyleo TN500 is intended for use with neonates and infants and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. It enables the controlled warming of patients with a body weight of up to 10 kg (22 lbs). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates and infants are kept warm in the patient compartment with humidifiable air which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer.

    The Babyleo TN500 provides controlled ambient conditions for neonates and infants. The following parameters are regulated, according to the intended use:

    • Temperature
    • Humidity
    • Oxygen (option)
    Device Description

    Babyleo TN500 is a warming therapy device intended to provide controlled conditions in the microenvironment for neonates and infants. Such conditions are characterized by the physical properties temperature, humidity, and oxygen.

    Intended to be a hybrid device, Babyleo TN500 can be operated as an incubator (according to IEC60601-2-19) or as a radiant warmer (according to IEC60601-2-21).

    Babyleo TN500 provides three heat sources:

    • the radiant warmer,
    • the convective heater and
    • the heated mattress (option).

    The three heat sources are synchronized to keep the temperature stable. If the optional heated mattress is not present, the patient bed is formed by the SoftBed mattress.

    The radiant warmer is mounted at the top of the main column. Thus, in radiant warmer operation, it enables the radiant heat to reach the patient bed where the infant is lying.

    The patient compartment is bounded by the hood and lateral walls surrounding the patient bed. The hood is connected to the main column via the hood arm and can be opened manually. When closing the hood, the device switches automatically from radiant warmer to incubator operation.

    In incubator operation the convective heater, which is located in the aggregate housing underneath the patient bed, provides warm air. Both, in radiant warmer and in incubator operation the optional heated mattress additionally warms the infant conductively.

    Patient compartment, aggregate housing and main column are mounted on the trolley. By means of foot pedals located on each side of the device the user can control a lifting column and adjust the height of the patient compartment. Four double-wheel casters and handles allow to move the Babyleo TN500.

    An optional rechargeable battery integrated into the trolley feeds the convective heater for a limited time in incubator operation when mains supply is not available. Thus, intrahospital transport of the device in incubator operation is enabled.

    For routine care interventions in incubator operations the patient compartment provides hand ports which automatically open if the corresponding hand port locks are pushed down. For larger interventions the access panels can be opened by lifting them and folding them down. Furthermore, the patient compartment obtains hose grommets to conduct hoses or lines into the patient compartment.

    An optional electronic scale is integrated into the Babyleo TN500 to weigh the patient. In the optional integrated drawer items needed for the patient care can be stored.

    In incubator operation the air inside the patient compartment can be humidified and enriched with oxygen. For humidification distilled water is provided via the Luer Lock connector to the humidification system where it is evaporated and delivered into the breathing gas.

    The optional oxygen regulation provides oxygen enrichment for the breathing gas. It can either be fed by the central gas supply or by oxygen cylinders.

    AI/ML Overview

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