Medline Digital Rectal Thermometer Sheath

FDA 510(k) K183431 · Medline Industries, Inc.

Substantially Equivalent

510(k) numberK183431

Submission

Device name
Medline Digital Rectal Thermometer Sheath
Applicant
Medline Industries, Inc.
Northfiled, IL, US
Received
December 11, 2018
Decision date
June 14, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLL – Continuous Measurement Thermometer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2910
Specialty
General Hospital

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.

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K240223FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional Metko Medikal VE Tibbi Cihazlar Dis Ticaret…10/25/2024SE

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Questions and answers

When was Medline Digital Rectal Thermometer Sheath cleared by the FDA?

Medline Digital Rectal Thermometer Sheath (K183431) received a 510(k) decision of Substantially Equivalent on June 14, 2019, 185 days after the submission was received.

What is the product code of K183431?

The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.