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510(k) Data Aggregation

    K Number
    K250470
    Device Name
    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
    Manufacturer
    Shenzhen AOJ Medical Technology Co., Ltd.
    Date Cleared
    2025-06-23

    (125 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.
    Device Description
    The ear thermometer is a handheld device that displays the temperature of the measured patient by measuring the thermal radiation of the eardrum. Measurement unit: °C or °F. The results can be displayed on LCD. The thermometers are powered by 1.5V×2 (AAA or AA) alkaline batteries, which can be used for people over three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum, which is converted into temperature measurement with the unit of °C or °F. All the models share the same critical components, intended use, working principle and similar product design, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, unit switch, low battery detection and high temperature indicator.
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    K Number
    K243000
    Device Name
    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
    Manufacturer
    Shenzhen Medke Technology Co., Ltd.
    Date Cleared
    2025-06-20

    (267 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. These devices are used by qualified medical professional only.
    Device Description
    The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Model: T1306, Description: Skin contact Temperature Probe, adult, reusable Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable
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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
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K243082
    Device Name
    Infrared Thermometer
    Manufacturer
    Guangzhou Daxin Health Technology Co., Ltd
    Date Cleared
    2025-04-25

    (207 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For T30: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment. For TE-82: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment. For TE-102 and TE-79: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.
    Device Description
    The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead. The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display. The results of measurements can also be transferred to the APP via Bluetooth for recording and display
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    K Number
    K250401
    Device Name
    AION TempShield™
    Manufacturer
    AION Biosystems Inc.
    Date Cleared
    2025-03-14

    (30 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.
    Device Description
    The AION TempShield™ is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet or certified gateway device. When the AION TempShield™ is connected to the device, it sends all temperature measurements automatically. The AION TempShield™ can be worn for up to 90 days to check current temperature and to allow viewing of historical temperature measurements. The device has the ability to share the data with the clinician if the clinician has established an AION account. The temperature measurements are in degrees Fahrenheit (°F), but can also be configured to display in degrees Celsius (°C). Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is used to turn on the device. The device communicates with a phone that has the AION TempShield app installed. The circuit card has two digital temperature sensors and a 32 MHz clock. The device is designed to have a minimum operating range of 10 meters and provides a 2 dBm signal to the radio. The AION TempShield™ is shipped in a shelf mode power condition (4uA) and can be on the shelf for 24 months before the battery is depleted below the 90-day threshold. The Bluetooth transmissions are encrypted using the on-board encryption. Each device has a random pairing code that must be typed in before the sensor and the mobile device can communicate. The modulation for the low energy Bluetooth is QFSK and the device has been certified and registered with the FCC for a class II device (at home use). The hospital use is covered under this classification. The smart phone application requires that the user allow for notifications, has access to location services, and enables both NFC and Bluetooth services to fully activate the AION TempShield™ Each AION TempShield™ has a unique serial number (UUID) and a random pin assigned. This information is accessible via a barcode on the outside of the package and from an NFC read (Similar to apple pay or google pay type of contact with the back of the phone. The NFC read will wake up the AION TempShield™ from deep sleep and initiate the pairing. Once the initial Bluetooth contact has been made the mobile application will present the 6-digit pairing number that the user must type in. Once this is done the mobile device will go into operational mode and send out temperature every five minutes. The Mobile app will look for temperature every five minutes with appropriate guard bands. Every 4hours the mobile application will request a full data offload from the AION TempShield™ to collect previous data that was not collected from the AION TempShield™. The AION TempShield Application communicates with the AION Core (Cloud monitoring service). This service will provide NIH recommendations for fever to the shield to provide indications (alerts)in the data for visualization for the User. There is no PHI stored in the AION cloud. The application has a home screen that displays the last read temperature. The application allows the user to put in activities, to view historical temperature history, and to select time windows to display data. For example: the application will allow the user to only view data for the past 12 hours. The total viewable data window is 48 hours. The application in the settings window will allow the user to view the UUID and will allow the user to replace the AION TempShield™ with another one. The Application will provide the user with the percentage of charge left in the device (battery life indication). When the battery life reaches 10% of charge left, the application will provide an alert that the user should get a new AION TempShield 100 (there will be approximately 1 week of continuous life available. At 5% life the notifications are once per two hours to replace the shield. The AION TempShield TM requires that the user place medical grade silicone tape to hold the AION TempShield™ in place. The AION TempShield™ is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iOS 11 or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.
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    K Number
    K243136
    Device Name
    Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2025-02-14

    (137 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
    Device Description
    The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor. The device is widely used for home healthcare, medical institutes and many other occasions.
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    K Number
    K240333
    Device Name
    Wearable Digital Thermometer (T31)
    Manufacturer
    Guangdong Genial Technology CO., Ltd.
    Date Cleared
    2024-10-30

    (268 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.
    Device Description
    The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device. The medical double-sided sticker are used to fix and stick the host in the user`s axilla. The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured. The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone. The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature. The wireless thermometer uses a rechargeable battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
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    K Number
    K240223
    Device Name
    FMT Disposable and Autoclavable Temperature Probes
    Manufacturer
    Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi
    Date Cleared
    2024-10-25

    (273 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements. FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use. FMT Disposable and Autoclavable Temperature Probes are intended by qualified medical professionals only.
    Device Description
    FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements. FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.
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    K Number
    K240220
    Device Name
    Aulisa Temperature Module (TM0002)
    Manufacturer
    Taiwan Aulisa Medical Devices Technologies, Inc.
    Date Cleared
    2024-09-27

    (245 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
    Device Description
    The Aulisa Temperature Module (TM0002) is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants which measures body temperature and sends the physiological data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, thirdparty mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for display and review. The software application can be downloaded from an official APP store, such as iOS APP store or Google Play. The Subject Device is reusable, and its intended environments of use are hospitals, medical facilities, home care, and subacute environments.
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    K Number
    K240077
    Device Name
    Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
    Manufacturer
    Covidien
    Date Cleared
    2024-08-20

    (223 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Product Code :

    FLL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.
    Device Description
    The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement. Features and benefits: - Fully enclosed sensor helps ensure patient safety - Satin Slip™ finish for easy insertion ● - Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables. The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package. The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2. - 1. Tube Blue - 2. Sleeve GP - 3. Thermistor Assembly - 4. Slurry Mixture The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A". A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device. Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.
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