# K180148: ATS Thermal Imaging Probe, ATS Patient Interface Unit

- Pathway: 510(k) (Special)
- Applicant: Securus Medical Group, Inc.
- Decided: Mar 21, 2018 after 61 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152402: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU), Securus,Inc (2016) Summary page 4.

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

Source page: https://510kreport.com/device/K180148
Methodology: https://510kreport.com/methodology