510(k) · Cleared
ClearedLevel 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket
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 Aug 1, 2006 as substantially equivalent to K011907 (Sims Level 1, Inc., 2001) after a 61-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 1, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904690 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK904690 Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 1991
- 1 generation backK011907 Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc. · 2001 · Recalled
- This deviceK061513 Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSmiths Medical Asd, 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 · 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 3 of 3 · 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 · cites it directly1descendant
- K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904690 | Temp Marq (TM) Convective Warming System | Marquest Medical Products, Inc. | 1991 | — |
| −1 | K011907 | Snuggle Warm 4000 Convective Warming System | Sims Level 1, Inc. | 2001 | 1 |
| 0 (this device) | K061513 | Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket | Smiths Medical Asd, Inc. | 2006 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K011907 | Snuggle Warm 4000 Convective Warming System | 2001 |
What descends from it? (3)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K083336 (Smiths Medical Asd, Inc., 2009) has gone furthest, with 2 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.
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/K061513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061513: Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061513
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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