510(k) · Cleared
ClearedLevel 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1 Snuggle Warm Left Lateral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · DWJ System, Thermal Regulating
Cleared on Jun 3, 2009 as substantially equivalent to K061513 (Smiths Medical Asd, Inc., 2006) and 2 other predicates after a 203-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 3, 2009
- Review
- 203 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K873745 (1987). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- 3 generations backK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- 2 generations backK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
- 1 generation backK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
- This deviceK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- Descendant · cites it directly · 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 ownK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| −3 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| −2 | K053645 | Modification to:Bair Hugger Temperature Management Systems | Arizant Healthcare, Inc. | 2006 | 4 |
| −1 | K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | 2006 | 6 |
| 0 (this device) | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model… | Smiths Medical Asd, Inc. | 2009 | — |
| +1 | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
| +2 | 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 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K061513 | Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSummary page 1…anket (SW-2019) Common Name: Convective Warming Blankets Classification Name: Thermal Regulating System (21 CFR 870.5900, Product Code DWJ) Predicate Device(s): o K061513 Smiths Medical ASD, Inc., Level I® Snuggle Warm® Pediatric Underbody Blanket and Level 1® Snuggle Warm® Large Pediatric Un… | 2006 |
| * | K011907 | Snuggle Warm 4000 Convective Warming SystemSummary page 1…iths Medical ASD, Inc., Level I® Snuggle Warm® Pediatric Underbody Blanket and Level 1® Snuggle Warm® Large Pediatric Underbody Blanket (SW-2009 and SW-2011) o K01 1907 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Snuggle Warm® 4000 Convective Warming System. The Snuggle Warm® 4000 Con… | 2001 |
| * | K060865 | Bair Paws Temperature Management System Model 850Summary page 2…00, SW-2001, SW-2002, SW-2003, SW-2004, SW-2005, SW-2006, SW-2007, and SW-201 0) Page 2 of 27 o K060865 Arizant Healthcare Inc., Bair Hugger® model 610 Full Body Surgical Blanket, model 555 Pediatric Underbody Blanket, model 5… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket… | 2014 | 1 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K141686 (Smith Medical Asd, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K061513.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083336: Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1 Snuggle Warm Left Lateral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083336
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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