FLL — Continuous Measurement Thermometer Class II
Classification Details
- Product Code
- FLL
- Device Class
- Class II
- Regulation Number
- 880.2910
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251160 | shenzhen med-link electronics tech co | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L | January 8, 2026 |
| K250470 | shenzhen aoj medical technology co | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 | June 23, 2025 |
| K243000 | shenzhen medke technology co | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature | June 20, 2025 |
| K250878 | jiangsu yuyue medical equipment and supply co | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT | May 22, 2025 |
| K243082 | guangzhou daxin health technology co | Infrared Thermometer | April 25, 2025 |
| K250401 | aion biosystems | AION TempShield | March 14, 2025 |
| K243136 | shenzhen finicare co | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 | February 14, 2025 |
| K240333 | guangdong genial technology co | Wearable Digital Thermometer (T31) | October 30, 2024 |
| K240223 | metko medikal ve tibbi cihazlar dis ticaret limited sirketi | FMT Disposable and Autoclavable Temperature Probes | October 25, 2024 |
| K240220 | taiwan aulisa medical devices technologies | Aulisa Temperature Module (TM0002) | September 27, 2024 |
| K240077 | covidien | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | August 20, 2024 |
| K233280 | steadysense | SteadyTemp | June 21, 2024 |
| K240648 | radiant innovation | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | June 5, 2024 |
| K240109 | zhuzhou goldenhot medical technology co | Medical electronic thermometer (FC01, FC02) | April 12, 2024 |
| K233192 | famidoc technology company limited | Wireless Smart Thermometer | April 5, 2024 |
| K230889 | wenzhou yosun medical technology co | Digital Thermometer | April 3, 2024 |
| K240023 | shenzhen yi fang blister packaging co | Probe Covers (YF-001, YF-002) | March 1, 2024 |
| K232473 | zhuhai yueja medical device technology co | Infrared Thermometer: Model YJ600 | February 9, 2024 |
| K231625 | wellvii | VitalDetect | February 2, 2024 |
| K232678 | guangdong genial technology co | Digital Thermometer, Model T28, T28L | January 31, 2024 |