510(k) · Cleared
ClearedBair Hugger (R) Patient Warming System-Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Medical, Inc. · DWJ System, Thermal Regulating
Cleared on Aug 14, 1990 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Aug 14, 1990
- Review
- 29 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK903360 Bair Hugger (R) Patient Warming System-ModificationAugustine Medical, Inc. · 1990
- Descendant · cites it directly · 7 of its ownK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- Descendant · 2 generations on · 6 of its ownK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 4 of its ownK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 2 of its ownK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- Descendant · 5 generations on · 1 of its ownK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K041686Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004 · cites it directly7descendants
- K053645Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · 2 generations on6descendants
- K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · 3 generations on4descendants
- K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc. · 2009 · 4 generations on2descendants
- K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903360 | Bair Hugger (R) Patient Warming System-Modification | Augustine Medical, Inc. | 1990 | — |
| +1 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| +2 | K053645 | Modification to:Bair Hugger Temperature Management Systems | Arizant Healthcare, Inc. | 2006 | 4 |
| +3 | K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | 2006 | 6 |
| +4 | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model… | Smiths Medical Asd, Inc. | 2009 | — |
| +5 | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041686 (Arizant Healthcare, Inc., 2004) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K903360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903360: Bair Hugger (R) Patient Warming System-Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903360
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026