Cleared Traditional

Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

K243000 · Shenzhen Medke Technology Co., Ltd. · General Hospital

Jun 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K243000 is an FDA 510(k) clearance for the Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Shenzhen Medke Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 20, 2025, 267 days after receiving the submission on September 26, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K243000 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	June 20, 2025
Days to Decision	267 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.