510(k) · Cleared
ClearedEquator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith Medical Asd, Inc. · DWJ System, Thermal Regulating
Cleared on Oct 28, 2014 as substantially equivalent to K011907 (Sims Level 1, Inc., 2001) and 4 other predicates after a 127-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Oct 28, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K873745 (1987). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- 4 generations backK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- 3 generations backK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
- 2 generations backK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
- 1 generation backK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- This deviceK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| −4 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| −3 | K053645 | Modification to:Bair Hugger Temperature Management Systems | Arizant Healthcare, Inc. | 2006 | 4 |
| −2 | K060865 | Bair Paws Temperature Management System Model 850 | Arizant Healthcare, Inc. | 2006 | 6 |
| −1 | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model… | Smiths Medical Asd, Inc. | 2009 | — |
| 0 (this device) | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
| +1 | 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 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K011907 | Snuggle Warm 4000 Convective Warming SystemSummary page 9…2003, SW-2004) Per 510(k) K083336 2003, SWU-2004, SWU-2007, SWU- Per 510(k) K011907 2010, SWU-2013, SWU-2014L, SWU-… | 2001 |
| * | K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Summary page 9…SW-2016, SW-2018, SW-2019) (models SWU-2001, SWU-2002, SWU- 2003, SW-2004) Per 510(k) K083336 2003, SWU-2004, SWU-2007, SWU- Per 510(k) K011907… | 2009 |
| * | K061513 | Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSummary page 14…(models SW-2009, SW-2011) (models SWU-2009, SWU-2011) Per 510(k) K061513 INTENDED USE Thermal regulation of a patient’s temperature in a Convective warming system for t… | 2006 |
| * | K040632 | Snuggle Warm 4000 Convective Warming System, Model SW4000Summary page 16…(models SW-2008) (models SWU-2008) Per 510(k) K040632 INTENDED USE Convective warming system for thermal regulation of a Convective warming system for… | 2004 |
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…Summary page 18…Temperature Management Unit Temperature Management System (model EQ-5000) (model EQ-5000HF) Per 510(k) K001149 (model SW-4000) Per 510(k) K011907 INTENDED USE… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181699 | Level 1 Convective Warmer | 2018 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K181699 (Smiths Medical Asd, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K011907.
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 Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments. The Snuggle Warm®…
Read the full statement (137 words)
The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and 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/K141686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141686: Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141686
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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