FLL — Continuous Measurement Thermometer Class II
FDA product code FLL covers "Continuous Measurement Thermometer", a Class II medical device regulated under 21 CFR 880.2910. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253162 | unimed medical supplies | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes | June 5, 2026 |
| 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 |