# K192210: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Fiab Spa
- Decided: Oct 10, 2019 after 57 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: 4 generations back to K863646 (1986). 5 ancestors in all.
2 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)
- K180047: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System, Fiab Spa (2018) Summary page 5.

## Most influential descendants
- 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. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the ESOTEST MULTI system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

Source page: https://510kreport.com/device/K192210
Methodology: https://510kreport.com/methodology