K251025 is an FDA 510(k) clearance for the Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049). This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.1920.
| 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 |
| Product Code | BZT — Stethoscope, Esophageal, With Electrical Conductors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1920 |