Cleared Traditional

Medline Digital Thermometer Non-Lubricated Probe Sheath

K211931 · Medline Industries, Inc. · General Hospital

Sep 2021

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K211931 is an FDA 510(k) clearance for the Medline Digital Thermometer Non-Lubricated Probe Sheath, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on September 20, 2021, 90 days after receiving the submission on June 22, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K211931 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2021
Decision Date	September 20, 2021
Days to Decision	90 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.