Cleared Traditional

Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)

K200946 · Taidoc Technology Corporation · General Hospital

Apr 2022

Decision

727d

Days

Class 2

Risk

About This 510(k) Submission

K200946 is an FDA 510(k) clearance for the Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 5, 2022, 727 days after receiving the submission on April 8, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K200946 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2020
Decision Date	April 05, 2022
Days to Decision	727 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.