# K070112: Rapidcool Patient Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medcool, Inc.
- Decided: Jul 13, 2007 after 183 days
- Product code: DWJ (System, Thermal Regulating)
- 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 K912051 (1991). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061023: Thermosuit System, Life Recovery Systems Hd, LLC (2006) Summary page 1.
- K811742: Hemotherm Model 400, Cincinnati Sub-Zero (1981) Summary page 1.

## Most influential descendants
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 (2011), 9 descendants of its own
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (2014), 4 descendants of its own
- K152266: Altrix Precision Temperature Management System (2016), 3 descendants of its own
- K161602: Arctic Sun Temperature Management System (2016), 3 descendants of its own
- K200225: Arctic Sun Stat Temperature Management System (2020), 1 descendant of its own

## Indications for use
The RapidCool Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.

Source page: https://510kreport.com/device/K070112
Methodology: https://510kreport.com/methodology