510(k) · Cleared
Recalled · Class II · 2014Snuggle Warm 4000 Convective Warming System, Model SW4000
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 Apr 27, 2004 after a 48-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK040632 Snuggle Warm 4000 Convective Warming System, Model SW4000Smiths Medical Asd, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- 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 · 1 of its ownK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK123946 Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · cites it directly2descendants
- K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · cites it directly1descendant
- K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012 · 2 generations on1descendant
- K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018 · 2 generations on0descendants
- K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040632 | Snuggle Warm 4000 Convective Warming System, Model SW4000 | Smiths Medical Asd, Inc. | 2004 | — |
| +1 | K101148 | Warm Air Model 135 Hyperthermia System and Blankets | Cincinnati Sub-Zero Products, Inc. | 2010 | 2 |
| +1 | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming… | Smith Medical Asd, Inc. | 2014 | — |
| +2 | K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets) | Cincinnati Sub-Zero Products, Inc. | 2012 | — |
| +2 | K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | 2018 | — |
| +2 | K123946 | Warmair Model 135 Hyperthermia System Including Filteredflo Blankets | Cincinnati Sub-Zero Products, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Snuggle Warm® 4000 Convective Warming System that includes non-sterile Convective… Named without a submission number |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Apr 22, 2014 | Class II | Z-1650-2014 | Process change control | The hose could separate from the blanket. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101148 (Cincinnati Sub-Zero Products, Inc., 2010) has gone furthest, with 2 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 | — |
What is it indicated for?
The device is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040632: Snuggle Warm 4000 Convective Warming System, Model SW4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040632
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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