# K140134: Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece

- Pathway: 510(k) (Traditional)
- Applicant: Starboard Medical, LLC
- Decided: Jun 16, 2014 after 150 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: 2 generations back to K854212 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111050: Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR, 18FR, 24FR, Starboard Medical, LLC (2012) Summary page 1.

## Indications for use
The Clarisonus Phus Esophageal Stethoscope with temperature sensor with attached earpiece is intendled for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds. - The Esophiageal Stethoscope with temperature sensor is intended for use when the esophiageal temperature is continuously monitored along with the auscultation of the heart and lung sounds. - The Esophageal/Rectal Temperature Probe is indicated for continuous monitoring of esophageal, rectal, and nasopharyngeal temtperatutres. The products are intended for use in surgical and critical care patients.

Source page: https://510kreport.com/device/K140134
Methodology: https://510kreport.com/methodology