Cleared Traditional

Mon-a-Therm? General Purpose Temperature Probe 400TM (90050, 90044)

K240077 · Covidien · General Hospital

Aug 2024

Decision

223d

Days

Class 2

Risk

About This 510(k) Submission

K240077 is an FDA 510(k) clearance for the Mon-a-Therm? General Purpose Temperature Probe 400TM (90050, 90044), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on August 20, 2024, 223 days after receiving the submission on January 10, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K240077 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2024
Decision Date	August 20, 2024
Days to Decision	223 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.