Cleared Traditional

K183431 - Medline Digital Rectal Thermometer Sheath

K183431 is the FDA 510(k) clearance for Medline Digital Rectal Thermometer Sheath by Medline Industries, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 317
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