# K222311: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Circa Scientific, Inc.
- Decided: May 25, 2023 after 297 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: 6 generations back to K863646 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200943: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System, Circa Scientific, LLC (2021) Summary page 4.

## Indications for use
The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA MATRIX12 M 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 CIRCA Monitor must be used in conjunction with the CIRCA MATRIX12 M 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 CIRCA Temperature Monitoring 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/K222311
Methodology: https://510kreport.com/methodology