# K180047: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Fiab Spa
- Decided: Nov 8, 2018 after 304 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: 3 generations back to K863646 (1986). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123361: Esotest Esophageal Temperature Probe and Temperature Monitoring System, Fiab Spa (2013) Summary page 4.

## Most influential descendants
- 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
- K222311: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (2023), 0 descendants of its own

## Indications for use
The ESOTEST MULTI Temperature Monitoring System is composed of ESOTEST MULTI Monitor and ESOTEST MULTI Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The ESOTEST MULTI Monitor must be used in conjunction with the ESOTEST MULTI Probe.

Source page: https://510kreport.com/device/K180047
Methodology: https://510kreport.com/methodology