(59 days)
Not Found
No.
The device description and performance studies do not mention the use of any AI, DNN, or ML models. It functions based on infrared energy detection and is validated through standard clinical performance studies, not AI model metrics.
No
The device is a thermometer, used for measuring body temperature, not for treating a condition.
No
The device measures body temperature, which is a symptom, but it does not diagnose medical conditions.
No
The device description clearly states it is a "hand-held, no-contact device," "battery-powered," and "utilizes infrared energy." These are physical hardware components. While one model (YHT107) has Bluetooth for data transmission, the core function of temperature measurement relies on the physical hardware of the thermometer.
No.
The device measures body temperature from the ear canal and is not intended for in vitro diagnostic examination of specimens derived from the human body.
N/A
Intended Use / Indications for 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear canal / tympanic membrane
Indicated Patient Age Range
all ages except preterm babies or babies who are small for gestational age.
Intended User / Care Setting
professional settings and the home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per the following standards:
- ISO 80601-2-56: 2017+ A1:2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature
This clinical study consisted of 154 subjects, of which 50 subjects are infants, 50 subjects are children, and 54 subjects are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults---greater than five years old). The clinical validation results demonstrated that the clinical data, represented by clinical bias, limits of agreement and clinical repeatability met the acceptance criteria of the clinical validation protocol.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
FDA 510(k) Clearance Letter - YUWELL® Infrared Ear Thermometer
Page 1
May 22, 2025
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
Fang (Fawn) Zhang
Official Correspondent
No.1 Baisheng Road Development Zone
Danyang, Jiangsu 212300
China
Re: K250878
Trade/Device Name: YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical electronic thermometer
Regulatory Class: Class II
Product Code: FLL
Dated: March 17, 2025
Received: March 24, 2025
Dear Fang (Fawn) Zhang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250878 - Fang (Fawn) Zhang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K250878 - Fang (Fawn) Zhang Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
For David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250878
Device Name: YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
- ☐ Prescription Use (Part 21 CFR 801 Subpart D)
- ☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
K250878- 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92
Date 510k summary prepared: May 22, 2025
I. SUBMITTER
510(k) Submitter: Jiangsu Yuyue Medical Equipment & Supply Co., LTD.
Address: No.1 Baisheng Road Development Zone Danyang Jiangsu 212300 China
Company Contact Person: Dr. Fang (Fawn) Zhang
Phone: (206) 639-1311
Email: Fawn.zhang@yuwell.com
II. DEVICE
Device Common Name: Clinical electronic thermometer
Device trade or proprietary name: YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Classification Name: Thermometer, Electronic, Clinical
Classification Regulation: 21 CFR §880.2910
Device Classification: Class II
Device Product Code: FLL
III. PREDICATE DEVICE
Device Trade Name: Braun Thermoscan® PRO 6000 Ear Thermometer
510(k): K152748
Product Code: FLL
IV. 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.
V. INDICATIONS FOR 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.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristics | Predicate Device K152748 | Subject Device K250878 | SAME/DIFFERENT | Comment |
|---|---|---|---|---|
| Type of Thermometer | IR Thermometer | IR Thermometer | Same | |
| Product Code | FLL | FLL | Same | |
| Regulation | 880.2910 | 880.2910 | Same | |
| Indications for use | The Braun Thermoscan® PRO 6000 Ear Thermometer is indicated for the intermittent measurement and monitoring of human body temperature for patients of all ages in a professional use environment. The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal. | The Infrared Ear Thermometer is indicated for the intermittent measurement of human body temperature from ear canal for people of all ages except for pre-term babies or babies who are small for gestational age. The device can be used in professional and home environments. The thermometer is not for emergency clinical conditions. The probe cover is used as a sanitary barrier between the infrared ear thermometer and the ear canal. | Different; see Note (1) below the table | |
| Patient Population | All populations | All populations except for premature babies and | Different; see Note (2) below the table |
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| Characteristics | Predicate Device K152748 | Subject Device K250878 | SAME/DIFFERENT | Comment |
|---|---|---|---|---|
| babies small for their gestational age | ||||
| RX/OTC Use | OTC | OTC | Same | |
| Measurement Sensor | IR | IR | Same | |
| Measurement Site | Ear | Ear | Same | |
| Contact/Non-contact | Non-contact | Non-contact | Same | |
| Temperature Range | 20℃-42.2℃ | 34.0-42.2℃ (93.2-108.0℉) | Similar; the temperature range conforms with ASTM E1965 and the subject device's temperature range is within that of the predicate device, which does not introduce new questions of safety and effectiveness. | |
| Accuracy (C/F) | 0.3℃ for 42℃ | ±0.2℃ (±0.4℉), 35.0℃–42.0℃ (95.0℉–107.6℉); ±0.3℃ (±0.5℉), 34.0℃–34.9℃ (93.2℉–94.8℉), 42.1℃–42.2℃ (107.8℉–108.0℉) | Same | |
| Display Resolution | 0.1℃/0.1℉ | 0.1℃/0.1℉ | Same | |
| Cel/Fahrenheit | Both | Both | Same | |
| Response Time | 2-3s |