# K982193: Esophageal Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Shore Medical, Inc.
- Decided: Sep 1, 1998 after 71 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062020: Lifesound Esophageal Stethoscope (2006), 0 descendants of its own

## Indications for use
The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided “packaged clean” and are for “single use” only.

Source page: https://510kreport.com/device/K982193
Methodology: https://510kreport.com/methodology