# K140635: Cocoon Convective Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Care Essentials Pty, Ltd.
- Decided: Jul 25, 2014 after 135 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873745 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053645: Modification to:Bair Hugger Temperature Management Systems, Arizant Healthcare, Inc. (2006) Summary page 2.
- K041686: Bair Hugger Temperature Management System, Arizant Healthcare, Inc. (2004) Summary page 2.

## Recalls of this device
- Jan 7, 2020 · Class II · Z-0986-2020: Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
- Jan 7, 2020 · Class II · Z-0987-2020: Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

## Indications for use
The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K140635
Methodology: https://510kreport.com/methodology