Cleared Traditional

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

K251025 is an FDA 510(k) clearance for Mon-a-Therm Esophageal Stethoscope with..., manufactured by Covidien, LLC. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 271-day FDA review.

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.

View all Covidien, LLC devices

FDA 510(k) Submission Details - K251025

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
131d slower than avg
Panel avg: 140d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BZT Stethoscope, Esophageal, With Electrical Conductors

All 26
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K251025.
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · Deroyal Industries, Inc. · Apr 2020
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
K140134 · Starboard Medical, LLC · Jun 2014
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
K111050 · Starboard Medical, LLC · Apr 2012
ESOPHAGEAL STETHOSCOPE
K982193 · Shore Medical, Inc. · Sep 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · Catheter Research, Inc. · Mar 1998
ARISTO ESOPHAGEAL STETHOSCOPE
K961060 · Aristo Medical Products, Inc. · Jun 1996