510(k) · Cleared
Recalled · Class II · 2020Cocoon Convective Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Essentials Pty, Ltd. · DWJ System, Thermal Regulating
Cleared on Jul 25, 2014 as substantially equivalent to K053645 (Arizant Healthcare, Inc., 2006) and 1 other predicate after a 135-day review. Its family tree reaches back 3 generations to 1987. It has been recalled 2 times.
- Decided
- Jul 25, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K873745 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- 2 generations backK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- 1 generation backK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
- This deviceK140635 Cocoon Convective Warming SystemCare Essentials Pty, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| −2 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| −1 | K053645 | Modification to:Bair Hugger Temperature Management Systems | Arizant Healthcare, Inc. | 2006 | 4 |
| 0 (this device) | K140635 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053645 | Modification to:Bair Hugger Temperature Management SystemsSummary page 2…Ltd Cocoon Convective Warming System Predicate Device(s) The Cocoon Convective Warming System is substantially equivalent to the following predicate device(s): " K053645 Bair Hugger Temperature Management System Model 750. * K041 686 Bair Hugger Temperature Management System Model 505. Device… | 2006 |
| * | K041686 | Bair Hugger Temperature Management SystemSummary page 2…on Convective Warming System is substantially equivalent to the following predicate device(s): " K053645 Bair Hugger Temperature Management System Model 750. * K041 686 Bair Hugger Temperature Management System Model 505. Device Description The Cocoon Convective Warming system incorporates the Con… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2020 | Class II | Z-0986-2020 | Other | 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 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K053645.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140635: Cocoon Convective Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140635
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026