Cleared Traditional

K183431 - Medline Digital Rectal Thermometer Sheath

K183431 is an FDA 510(k) clearance for Medline Digital Rectal Thermometer Sheath, 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 185-day FDA review.

K183431 · Medline Industries, Inc. · General Hospital
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Jun 2019
Decision
185d
Days
Class 2
Risk

K183431 is an FDA 510(k) clearance for the Medline Digital Rectal Thermometer 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 June 14, 2019 after a review of 185 days - an extended review cycle.

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 - K183431

510(k) Number K183431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date June 14, 2019
Days to Decision 185 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
56d slower than avg
Panel avg: 129d · This submission: 185d
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 K183431.
Infrared Ear/Forehead Thermometer
K190873 · Joytech Healthcare Co. , Ltd. · Jul 2019
Microlife Digital Infrared Ear Thermometer
K183663 · Microlife Intellectual Property GmbH · Jul 2019
Med-link Temperature Probes
K182667 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jun 2019
Wireless Intelligent Thermometer
K182437 · Shenzhen Jumper Medical Equipment Co., Ltd. · May 2019
Infrared thermometer
K182597 · Shenzhen Pango Electronic Co., Ltd. · Apr 2019
Tyto Thermometer
K190242 · Tyto Care , Ltd. · Mar 2019