# K071358: Reprieve Endovascular Temperature Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Radiant Medical
- Decided: Jun 1, 2007 after 17 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: 4 generations back to K811742 (1981). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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.
- K063405: Reprieve Endovascular Temperature Therapy System, Radiant Medical (2007) Summary page 1.
- K022366: Celsius Control System, Innercool Therapies (2003) Summary page 1.
- K030421: Alsius Coolgard 3000 & Alsius Catheter System, Alsius Corp. (2003) Summary page 1.

## Indications for use
The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Source page: https://510kreport.com/device/K071358
Methodology: https://510kreport.com/methodology