# K152402: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

- Pathway: 510(k) (Traditional)
- Applicant: Securus,Inc
- Decided: Mar 4, 2016 after 192 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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
- K180148: ATS Thermal Imaging Probe, ATS Patient Interface Unit (2018), 0 descendants of its own

## Indications for use
The IRTS Probe is intended for continuous esophageal temperature monitoring. The IRTS Patient Monitoring Unit (PMU) with Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

Source page: https://510kreport.com/device/K152402
Methodology: https://510kreport.com/methodology