Infrared Ear Thermometer
FDA 510(k) K180387 · Hetaida Technology Co., Ltd.
510(k) numberK180387
Submission
- Device name
- Infrared Ear Thermometer
- Applicant
- Hetaida Technology Co., Ltd.
Foshan City, CN - Received
- February 12, 2018
- Decision date
- January 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLL – Continuous Measurement Thermometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2910
- Specialty
- General Hospital
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Other 510(k)s with product code FLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | Unimed Medical Supplies, Inc. | 06/05/2026SE |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 01/08/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 06/23/2025SE |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional | Shenzhen Medke Technology Co., Ltd. | 06/20/2025SE |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 05/22/2025SE |
| K243082 | Infrared ThermometerFLL · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 04/25/2025SE |
| K250401 | AION TempShieldFLL · Traditional | Aion Biosystems, Inc. | 03/14/2025SE |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional | Shenzhen Finicare Co., Ltd. | 02/14/2025SE |
| K240333 | Wearable Digital Thermometer (T31)FLL · Traditional | Guangdong Genial Technology Co., Ltd. | 10/30/2024SE |
| K240223 | FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional | Metko Medikal VE Tibbi Cihazlar Dis Ticaret… | 10/25/2024SE |
More from Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
| 510(k) | Device | Decision |
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| K243661 | Electronic Blood Pressure MonitorDXN · Special | 02/07/2025SE |
| K241202 | Electric nasal aspirator (HTD2601US)BTA · Traditional | 07/01/2024SE |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602USDXN · Traditional | 12/05/2023SE |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CFLL · Special | 02/25/2021SE |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823USFLL · Traditional | 01/05/2021SE |
| K171888 | Non-contact infrared body thermometerFLL · Traditional | 07/23/2018SE |
| K180385 | Infrared Body ThermometerFLL · Traditional | 05/11/2018SE |
Questions and answers
When was Infrared Ear Thermometer cleared by the FDA?
Infrared Ear Thermometer (K180387) received a 510(k) decision of Substantially Equivalent on January 10, 2019, 332 days after the submission was received.
What is the product code of K180387?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.