# K062020: Lifesound Esophageal Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Novamed, LLC
- Decided: Sep 5, 2006 after 50 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 K864858 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864858: Lifesound (TM) Esophageal Stethoscope W/Thermistor, Biomedical Concepts, Inc. (1987) Summary page 1.
- K982193: Esophageal Stethoscope, Shore Medical, Inc. (1998) Summary page 1.

## Indications for use
Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".

Source page: https://510kreport.com/device/K062020
Methodology: https://510kreport.com/methodology