# K080908: Innercool Therapies, Inc., Rapidblue System

- Pathway: 510(k) (Special)
- Applicant: Innercool Therapies, Inc.- A Delaware Corporation
- Decided: Oct 17, 2008 after 199 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K811742 (1981). 25 ancestors in all.
1 later device descends 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)
- K033623: Celsius Control System, Innercool Therapies, Inc. (2004) Summary page 1.

## Most influential descendants
- K152946: Tempedy (2016), 0 descendants of its own

## Recalls of this device
- Jan 13, 2014 · Class II · Z-0845-2014: Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.

## Indications for use
The RapidBlue TM 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/K080908
Methodology: https://510kreport.com/methodology