510(k) · Cleared
ClearedLevel 1 Convective Warmer
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 Jul 26, 2018 as substantially equivalent to K141686 (Smith Medical Asd, Inc., 2014) after a 29-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Jul 26, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873745 (1987). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- 5 generations backK041686 Bair Hugger Temperature Management SystemArizant Healthcare, Inc. · 2004
- 4 generations backK053645 Modification to:Bair Hugger Temperature Management SystemsArizant Healthcare, Inc. · 2006 · Recalled
- 3 generations backK060865 Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc. · 2006 · Recalled
- 2 generations backK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
- 1 generation backK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
- This deviceK181699 Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| −5 | K041686 | Bair Hugger Temperature Management System | Arizant Healthcare, Inc. | 2004 | — |
| −4 | 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 |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Summary page 5…te Device Name Product Code Clearance Date Equator Convective Warmer DWJ K141686 Cleared on October 28, 2014 General Device Description: The Level 1… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 14 ancestors have a recall of any class.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Level 1® 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 Level 1® Convective Warmer 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/K181699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181699: Level 1 Convective Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181699
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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