Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
FDA 510(k) K243136 · Shenzhen Finicare Co., Ltd.
Submission
- Device name
- Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
- Applicant
- Shenzhen Finicare Co., Ltd.
Shenzhen, CN - Received
- September 30, 2024
- Decision date
- February 14, 2025
- 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 |
| 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 |
| K240220 | Aulisa Temperature Module (TM0002)FLL · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 09/27/2024SE |
More from Taiwan Aulisa Medical Devices Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126…DXN · Special | 10/02/2025SE |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120…DXN · Special | 10/04/2024SE |
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211…DXN · Traditional | 09/18/2023SE |
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-…DXN · Traditional | 05/31/2022SE |
| K181215 | Infrared ThermometerFLL · Traditional | 01/02/2019SE |
Questions and answers
When was Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) cleared by the FDA?
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) (K243136) received a 510(k) decision of Substantially Equivalent on February 14, 2025, 137 days after the submission was received.
What is the product code of K243136?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.