Cleared Traditional

Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)

K243136 · Shenzhen Finicare Co., Ltd. · General Hospital

Feb 2025

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K243136 is an FDA 510(k) clearance for the Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Shenzhen Finicare Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 14, 2025, 137 days after receiving the submission on September 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K243136 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	February 14, 2025
Days to Decision	137 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
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.