# K022366: Celsius Control System

- Pathway: 510(k) (Traditional)
- Applicant: Innercool Therapies
- Decided: Jan 27, 2003 after 189 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). 13 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002577: Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads, Medivance, Inc. (2000) Summary page 1.
- K003349: Allon 2001 Modified, Mtre Advanced Technology, Ltd. (2000) Summary page 1.
- K902756: Tropi-Cool, Seabrook Medical Systems, Inc. (1990) Summary page 1.
- K811743: Maxitherm, Cincinnati Sub-Zero (1981) Summary page 1.
- K912051: Medi-Therm (Mta-5900) & Detachable Hoses, Gaymar Industries, Inc. (1991) Summary page 1.
- K012512: Setpoint Endovascular Temperature Management System, Radiant Medical (2002)

## Most influential descendants
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own
- K052443: Icy Catheter, Model IC-3893A (2005), 8 descendants of its own
- K070161: Quattro Catheter Model IC4593 (2007), 7 descendants of its own
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), 6 descendants of its own
- K081936: Solex Catheter, Model SL2593 (2008), 5 descendants of its own

## Indications for use
The Celsius ControlTMSystem is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Source page: https://510kreport.com/device/K022366
Methodology: https://510kreport.com/methodology