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

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Dec 29, 2025 after 271 days
- Product code: BZT (Stethoscope, Esophageal, With Electrical Conductors)
- Device class: 2
- Regulation: 21 CFR 868.1920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811862 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811862: HI-LO Temp Esophageal Stethoscope, Mallinckrodt Critical Care (1981) Summary page 5.

## Indications for use
The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is indicated for use in the routine monitoring of temperature, as well as heart and respiratory sounds, in an anesthetized patient. The device is intended for insertion into the esophagus. The intended target populations for the Mon-a-Therm TM products are pediatrics and adults.

Source page: https://510kreport.com/device/K251025
Methodology: https://510kreport.com/methodology