# K193027: Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 2, 2020 after 155 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 K925789 (1993). 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)
- K925789: Debusk Temp. Syst. Esophageal Stethoscope, Deroyal Industries, Inc. (1993) Summary page 4.

## Indications for use
The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.

Source page: https://510kreport.com/device/K193027
Methodology: https://510kreport.com/methodology