Cleared Traditional

K251025 - Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K251025 is an FDA 510(k) clearance for the Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 900.... Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 29, 2025 after a review of 271 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K251025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 139d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
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 Anesthesiology devices follow this clearance model.