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510(k) Data Aggregation

    K Number
    K252805

    Validate with FDA (Live)

    Date Cleared
    2026-02-17

    (167 days)

    Product Code
    Regulation Number
    870.2700
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    YUWELL® Finger Pulse Oximeters are non-invasive, non-sterile, reusable, and spot-checking devices that measure and display SpO₂ and pulse rate (PR) via the patient's finger. They are indicated for use in adults and children (weight > 30 kg) and are intended for professional and home settings. These devices are unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.

    Device Description

    YUWELL® Finger Pulse Oximeter (the Oximeter) is a finger pulse oximeter designed to measure functional oxygen saturation (SpO₂) of arterial hemoglobin and pulse rate (PR) in adults and children (weight > 30 kg). The device operates by detecting changes in light absorption caused by blood pulsation in the vascular bed, which are used to determine SpO₂ and PR. It contains light-emitting diodes (LEDs) and a photodetector, with the photodetector positioned on the opposite side of the probe from the LEDs. SpO₂ and PR are displayed on the device's LED/OLED screen, providing a visual pulse indicator that blinks in sync with the detected PR.

    The Oximeter is powered by two AAA alkaline batteries and does not feature alarms. The YX310 and YX110 models can transfer data to a mobile device wirelessly whereas the YX105 and YX106 models do not transfer data.

    AI/ML Overview

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