Cleared Traditional

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

K250470 · Shenzhen AOJ Medical Technology Co., Ltd. · General Hospital
Jun 2025
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K250470 is an FDA 510(k) clearance for the Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 23, 2025, 125 days after receiving the submission on February 18, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number K250470 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date June 23, 2025
Days to Decision 125 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.

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