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    K Number
    K250878
    Device Name
    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
    Date Cleared
    2025-05-22

    (59 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K152748
    Why did this record match?
    Device Name :

    YUWELL**®** Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Infrared Ear Thermometer is indicated for intermittent measurement of human body temperature from the ear canal. The device can be used by people of all ages except preterm babies or babies who are small for gestational age. The thermometer is intended for use in professional settings and the home environment. It is not for emergency clinical conditions.

    Device Description

    YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held, no-contact device is battery-powered and utilizes infrared energy emitted in the subject's tympanic membrane to determine human body temperature. The thermometer provides temperature readings in just 2 seconds. It is suitable for individuals of all ages except preterm babies or babies who are small for gestational age. The Infrared Ear Thermometer YHT107 can transmit the temperature readings via Bluetooth, whereas the YHT100 does not have data transmission capability.

    AI/ML Overview

    Here's a detailed breakdown of the acceptance criteria and study information for the YUWELL® Infrared Ear Thermometer, extracted from the provided FDA 510(k) clearance letter:

    YUWELL® Infrared Ear Thermometer (YHT100; YHT107) Acceptance Criteria and Study Details

    The YUWELL® Infrared Ear Thermometer (YHT100; YHT107) is indicated for intermittent measurement of human body temperature from the ear canal in professional and home environments, for people of all ages except preterm babies or babies who are small for gestational age.

    1. Table of Acceptance Criteria and Reported Device Performance

    The core performance acceptance criteria are related to temperature accuracy, as specified by the standards ISO 80601-2-56 and ASTM E1965.

    CharacteristicAcceptance Criteria (Standard Specification)Reported Device Performance (Subject Device)
    AccuracyFor 35.0℃–42.0℃ (95.0℉–107.6℉): ±0.2℃ (±0.4℉)Achieved: ±0.2℃ (±0.4℉) for 35.0℃–42.0℃ (95.0℉–107.6℉)
    For 34.0℃–34.9℃ (93.2℉–94.8℉) & 42.1℃–42.2℃ (107.8℉–108.0℉): ±0.3℃ (±0.5℉)Achieved: ±0.3℃ (±0.5℉) for 34.0℃–34.9℃ (93.2℉–94.8℉) and 42.1℃–42.2℃ (107.8℉–108.0℉)
    Temperature RangeConforms with ASTM E1965 (Predicate range: 20℃-42.2℃)34.0-42.2℃ (93.2-108.0℉)
    Display Resolution0.1℃/0.1℉ (Matches predicate)0.1℃/0.1℉
    Response TimeNot explicitly stated as a strict acceptance criterion with quantitative limits, but differences were evaluated. (Predicate: 2-3s)
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