# K083662: Criticool

- Pathway: 510(k) (Traditional)
- Applicant: Mtre Advanced Technology, Ltd.
- Decided: Mar 26, 2009 after 106 days
- Product code: DWJ (System, Thermal Regulating)
- 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: 2 generations back to K003349 (2000). 6 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000, Medivance, Inc. (2007) Summary page 1.
- K024128: Allon 2001 Version 5, Mtre Advanced Technology, Ltd. (2003) 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
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems (2010), 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

## Recalls of this device
- Jul 20, 2021 · Class II · Z-0153-2023: Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failur

## Indications for use
The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Source page: https://510kreport.com/device/K083662
Methodology: https://510kreport.com/methodology