# K123361: Esotest Esophageal Temperature Probe and Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Fiab Spa
- Decided: Feb 27, 2013 after 119 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- 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 K863646 (1986). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112376: S-Cath Esophageal Temperature Probe and Temperature Monitoring System, Circa Scientific, LLC (2011)

## Most influential descendants
- K180047: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (2018), 3 descendants of its own
- K192210: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System (2019), 2 descendants of its own
- K200943: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (2021), 1 descendant of its own
- K152402: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) (2016), 1 descendant of its own
- K222311: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (2023), 0 descendants of its own

## Indications for use
ESOTEST Probe Esotest probe is intended for continuous esophageal temperature monitomig, ESOTEST Monitor Esotest monitor is intended for display continuous temperature measurement (0 C) from 3 sensors temperature probe.

Source page: https://510kreport.com/device/K123361
Methodology: https://510kreport.com/methodology