Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
FDA 510(k) K251025 · Covidien, LLC
510(k) numberK251025
Submission
- Device name
- Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- Applicant
- Covidien, LLC
Boulder, CO, US - Received
- April 2, 2025
- Decision date
- December 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZT – Stethoscope, Esophageal, With Electrical Conductors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1920
- Specialty
- Anesthesiology
Other 510(k)s with product code BZT
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|---|---|---|---|
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope…BZT · Traditional | Starboard Medical, LLC | 06/16/2014SE |
| K111050 | Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…BZT · Traditional | Starboard Medical, LLC | 04/12/2012SE |
| K092716 | Esophageal StethoscopeBZT · Traditional | Truer Medical, Inc. | 09/17/2009SE |
| K072621 | Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorBZT · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/13/2007SE |
| K062020 | Lifesound Esophageal StethoscopeBZT · Traditional | Novamed, LLC | 09/05/2006SE |
| K982193 | Esophageal StethoscopeBZT · Traditional | Shore Medical, Inc. | 09/01/1998SE |
| K973839 | Disposable Esophageal StethoscopeBZT · Traditional | Catheter Research, Inc. | 03/19/1998SE |
| K961060 | Aristo Esophageal StethoscopeBZT · Traditional | Aristo Medical Products, Inc. | 06/19/1996SE |
| K953793 | IntroscopeBZT · Traditional | Polamedco, Inc. | 11/29/1995SE |
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Questions and answers
When was Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) cleared by the FDA?
Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025) received a 510(k) decision of Substantially Equivalent on December 29, 2025, 271 days after the submission was received.
What is the product code of K251025?
The FDA product code is BZT – Stethoscope, Esophageal, With Electrical Conductors, a Class II (moderate risk) device regulated under 21 CFR 868.1920.