# K042388: Radiant Medical Endocatheter Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Medical
- Decided: Oct 28, 2004 after 56 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K811742 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024327: Setpoint Endovascular Temperature Probe, Radiant Medical (2003) Summary page 1.

## Indications for use
The Radiant Medical Endocatheter Temperature Probe is indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.

Source page: https://510kreport.com/device/K042388
Methodology: https://510kreport.com/methodology
