# K112376: S-Cath Esophageal Temperature Probe and Temperature Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Circa Scientific, LLC
- Decided: Aug 31, 2011 after 14 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: 1 generation back to K863646 (1986). 2 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K863646: Esophageal Rectal Temperature Probe, Respiratory Support Products, Inc. (1986) Summary page 1.
- K913083: BI-Temp Temperature Monitor TM-201D, Respiratory Support Products, Inc. (1991) Summary page 1.

## Most influential descendants
- K123361: Esotest Esophageal Temperature Probe and Temperature Monitoring System (2013), 6 descendants of its own
- 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

## Indications for use
The Esophageal Temperature Probe is intended for continuous temperature monitoring. The radiopaque probe is designed for placement in the esophagus. Display continuous temperature measurement (0 C) from 12-sensor temperature probe.

Source page: https://510kreport.com/device/K112376
Methodology: https://510kreport.com/methodology