Cleared Traditional

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · General Hospital

Jan 2026

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K251160 is an FDA 510(k) clearance for the Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 8, 2026, 268 days after receiving the submission on April 15, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K251160 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2025
Decision Date	January 08, 2026
Days to Decision	268 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.