# K111050: Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR, 18FR, 24FR

- Pathway: 510(k) (Traditional)
- Applicant: Starboard Medical, LLC
- Decided: Apr 12, 2012 after 363 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 K854212 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863646: Esophageal Rectal Temperature Probe, Respiratory Support Products, Inc. (1986) Summary page 1.
- K854212: Acoustascope Esophageal Stethoscope W/Temp Sensor, Respiratory Support Products, Inc. (1986) Summary page 1.

## Most influential descendants
- K140134: Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece (2014), 0 descendants of its own

## Indications for use
The Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum. The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.

Source page: https://510kreport.com/device/K111050
Methodology: https://510kreport.com/methodology