# K063405: Reprieve Endovascular Temperature Therapy System

- Pathway: 510(k) (Special)
- Applicant: Radiant Medical
- Decided: Jan 8, 2007 after 60 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811742 (1981). 8 ancestors in all.
1 later device descends 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)
- K012512: Setpoint Endovascular Temperature Management System, Radiant Medical (2002) Summary page 1.

## Most influential descendants
- K071358: Reprieve Endovascular Temperature Therapy System (2007), 0 descendants of its own

## Indications for use
The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care

Source page: https://510kreport.com/device/K063405
Methodology: https://510kreport.com/methodology