# K232502: Cocoon Convective Warming System, Model CWS7000

- Pathway: 510(k) (Traditional)
- Applicant: Care Essentials Pty, Ltd.
- Decided: Feb 21, 2024 after 187 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: 4 generations back to K873745 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060865: Bair Paws Temperature Management System Model 850, Arizant Healthcare, Inc. (2006) Summary page 4.

## Indications for use
The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.

Source page: https://510kreport.com/device/K232502
Methodology: https://510kreport.com/methodology