510(k) · Cleared
Recalled · Class II · 2018Bair Paws Temperature Management System Model 850
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 Apr 24, 2006 as substantially equivalent to K053645 (Arizant Healthcare, Inc., 2006) after a 25-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 24, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K873745 (1987). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 deviceK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK232502 Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc. · 2009 · cites it directly2descendants
- K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · 2 generations on1descendant
- K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd. · 2024 · cites it directly0descendants
- K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018 · 3 generations on0descendants
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) | K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | 2006 | — |
| +1 | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model… | Smiths Medical Asd, Inc. | 2009 | — |
| +2 | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
| +1 | K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024 | — |
| +3 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K053645 | Modification to:Bair Hugger Temperature Management SystemsSummary page 1…mmon/usual name: Hyper/Hypothermia System Classification name: System, Thermal, Regulating, DWJ Equivalent marketed device: Bair Hugger® Temperature Management System (K053645) Device description: The Bair Hugger family of temperature management systems consist of a portable forced- air temperature mana… | 2006 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jan 23, 2018 | Class II | Z-0599-2018 | Finished device change control | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. |
| Jan 23, 2018 | Class II | Z-0598-2018 | Finished device change control | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. |
| 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… |
The 5 latest of 6 recalls; the web page lists all.
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 1.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K083336 (Smiths Medical Asd, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 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.
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/K060865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060865: Bair Paws Temperature Management System Model 850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060865
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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