510(k) · Cleared
ClearedHot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103
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 Dec 10, 2009 as substantially equivalent to K051419 (Inditherm Medical, 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2002. 6 later devices descend from it.
- Decided
- Dec 10, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K011859 (2002). 8 ancestors in all, the oldest K960167 (1996). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 2 generations backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- 1 generation backK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- This deviceK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
- Descendant · cites it directly · 4 of its ownK094056 Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
- Descendant · 2 generations on · 3 of its ownK201779 HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · Recalled
- Descendant · 3 generations on · 2 of its ownK220941 HotDog Temperature Management SystemAugustine Temperature Management · 2022 · Recalled
- Descendant · 4 generations on · 1 of its ownK230866 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023 · Recalled
- Descendant · 5 generations on · 0 of its ownK232627 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010 · cites it directly4descendants
- K201779HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · 2 generations on3descendants
- K220941HotDog Temperature Management SystemAugustine Temperature Management · 2022 · 3 generations on2descendants
- K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023 · 4 generations on1descendant
- K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −2 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| −1 | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | Inditherm Medical | 2006 | — |
| 0 (this device) | K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 | Augustine Biomedical & Design, LLC | 2009 | — |
| +1 | K094056 | Hotdog Multi Function Controller | Augustine Biomedical & Design, LLC | 2010 | — |
| +2 | K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020 | 4 |
| +3 | K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022 | 4 |
| +4 | K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023 | 4 |
| +5 | K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Summary page 1…Product Code DWJ (21 CFR Part 870.5900) Common Name Thermal Regulating System Predicate Device Indithermn Patient Wanming System - K05 1419 Hot Dog Patient Warming System - K052392 Bair Hugger Patient Warming System M… | 2006 |
| * | K052392 | Hot Dog Patient Warming SystemSummary page 1…Thermal Regulating System Predicate Device Indithermn Patient Wanming System - K05 1419 Hot Dog Patient Warming System - K052392 Bair Hugger Patient Warming System Model 505 - K960 167 Bair Hugger Patient W… | 2006 |
| * | K960167 | System, Thermal Regulating 74-DWJSummary page 1…ent Wanming System - K05 1419 Hot Dog Patient Warming System - K052392 Bair Hugger Patient Warming System Model 505 - K960 167 Bair Hugger Patient Warming System Model 750 - KOO] 149 Device Description The Hot bog Patient… | 1996 |
| Kept off the family tree | K001149 | FDA’s K001149 is Augustine Medical Bair Huuger, Model 750 Total Temperature Management… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
What descends from it? (6)
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K094056 (Augustine Biomedical & Design, LLC, 2010) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K051419.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Hot Dog Patient Warming Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad.
The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092807: Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092807
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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