510(k) · Cleared
ClearedHot Dog Patient Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Biomedical & Design, LLC · DWJ System, Thermal Regulating
Cleared on May 4, 2006 as substantially equivalent to K001149 (Augustine Medical, Inc., 2000) and 1 other predicate after a 246-day review. Its family tree reaches back 2 generations to 2000. 35 later devices descend from it.
- Decided
- May 4, 2006
- Review
- 246 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991684 (2000). 3 ancestors in all. 35 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 1 generation backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- This deviceK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- Descendant · cites it directly · 20 of its ownK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- Descendant · 2 generations on · 19 of its ownK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- Descendant · 3 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 4 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 4 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010 · cites it directly20descendants
- K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013 · 2 generations on19descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 3 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 4 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −1 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| 0 (this device) | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| +1 | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| +2 | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| +3 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +4 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +4 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750… | 2000 |
| * | K022903 | ChillbusterSummary page 1…Patient Warming System Predicate Devices: Bair Hugger Model 750 - Arizant Medical, Inc. (KOO1 149) Chillbuster - Microtek Medical, Inc. (K022903) Device The Hot Dog Patient Warming System is designed to compensate for body Description: heat loss… | 2002 |
What descends from it? (35)
See all 355 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093244 | Unique Temp Warming Blankets, Model 8001140XXX | 2010 | 20 |
| K112488 | Hotdog Patient Warming System | 2011 | 6 |
| K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 | 2009 | 6 |
| K094056 | Hotdog Multi Function Controller | 2010 | 4 |
| K201779 | HotDog Temperature Management Controller | 2020 | 3 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K093244 (Geratherm Medical AG, 2010) has gone furthest, with 20 descendants of its own.
- 9 other devices also cite its predicate K001149.
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 Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming System should be used in circumstances in which patients could become cold.
The system in intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units and on medical/surgical floors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052392: Hot Dog Patient Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052392
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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