510(k) · Cleared
Recalled · 2009Modification to:Bair Hugger Temperature Management Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arizant Healthcare, Inc. · DWJ System, Thermal Regulating
Cleared on Mar 9, 2006 as substantially equivalent to K041686 (Arizant Healthcare, Inc., 2004) after a 69-day review. Its family tree reaches back 2 generations to 1987. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 9, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873745 (1987). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- 1 generation backK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- This deviceK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK232502 Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · cites it directly4descendants
- K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc. · 2009 · 2 generations on2descendants
- K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · 3 generations on1descendant
- K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024 · 2 generations on0descendants
- K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| −1 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| 0 (this device) | K053645 | Modification to:Bair Hugger Temperature Management Systems | Arizant Healthcare, Inc. | 2006 | — |
| +1 | K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | 2006 | 6 |
| +2 | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model… | Smiths Medical Asd, Inc. | 2009 | — |
| +3 | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
| +2 | K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024 | — |
| +4 | K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K041686 | Bair Hugger Temperature Management SystemSummary page 1…ommon/usual name: Hyper/Hypothermia System Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Bair Hugger temperature management system (K041686). Device description: The Bair Hugger family of temperature management systems consist of a portable forced- air temperature man… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2009 | Not classified | Z-0897-2010 | Nonconforming Material/Component | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature… |
| Dec 17, 2009 | Not classified | Z-0898-2010 | Nonconforming Material/Component | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature… |
| Dec 17, 2009 | Not classified | Z-0895-2010 | Nonconforming Material/Component | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature… |
| Dec 17, 2009 | Not classified | Z-0896-2010 | Nonconforming Material/Component | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K060865 (Arizant Healthcare, Inc., 2006) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K041686.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Bair Hugger family of temperature management systems are 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 temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053645: Modification to:Bair Hugger Temperature Management Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053645
Report an extraction error
Are you the manufacturer?
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