# K033623: Celsius Control System

- Pathway: 510(k) (Traditional)
- Applicant: Innercool Therapies, Inc.
- Decided: May 21, 2004 after 185 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). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 27 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.
- K014241: Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D, Alsius Corp. (2003) Summary page 1.
- K030421: Alsius Coolgard 3000 & Alsius Catheter System, Alsius Corp. (2003) Summary page 1.

## Most influential descendants
- K080908: Innercool Therapies, Inc., Rapidblue System (2008), 1 descendant of its own
- K152946: Tempedy (2016), 0 descendants of its own

## Indications for use
The Celsius ControlTM System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who required access to the central venous circulation and who are intubated and sedated.

Source page: https://510kreport.com/device/K033623
Methodology: https://510kreport.com/methodology