Cleared Traditional

Infrared Thermometer

K243082 · Guangzhou Daxin Health Technology Co., Ltd. · General Hospital

Apr 2025

Decision

207d

Days

Class 2

Risk

About This 510(k) Submission

K243082 is an FDA 510(k) clearance for the Infrared Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Guangzhou Daxin Health Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 25, 2025, 207 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	K243082 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	April 25, 2025
Days to Decision	207 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.