Cleared Traditional

K211931 - Medline Digital Thermometer Non-Lubricated Probe Sheath

K211931 is an FDA 510(k) clearance for Medline Digital Thermometer Non-Lubrica..., manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K211931 · Medline Industries, Inc. · General Hospital
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Sep 2021
Decision
90d
Days
Class 2
Risk

K211931 is an FDA 510(k) clearance for the Medline Digital Thermometer Non-Lubricated Probe Sheath. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on September 20, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K211931

510(k) Number K211931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 523
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K211931.
ThermArt (Model IR-EFT)
K202481 · Comper Chuangxiang (Beijing) Technology Co., Ltd. · Sep 2021
DT100 Digital Thermometer
K203731 · Smart Technology Co., Ltd. · Sep 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · Yibin Junxin Electronics Technology Co., Ltd. · Sep 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · Longnan Renzhong Medical Equipment Co., Ltd. · Sep 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352 · Putian Hanjiang Huafeng Plastic Co., Ltd. · Sep 2021
Infrared Thermometer, Model: HW-1
K211583 · Dongguan Simzo Electronic Technology Co., Ltd. · Sep 2021