Cleared Traditional

Mon-a-Therm? Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

K251025 · Covidien, LLC · Anesthesiology
Dec 2025
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K251025 is an FDA 510(k) clearance for the Mon-a-Therm? Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049), a Stethoscope, Esophageal, With Electrical Conductors (Class II — Special Controls, product code BZT), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 29, 2025, 271 days after receiving the submission on April 2, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1920.

Submission Details

510(k) Number K251025 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2025
Decision Date December 29, 2025
Days to Decision 271 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZT — Stethoscope, Esophageal, With Electrical Conductors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1920

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