510(k) · Cleared
Recalled · Class II · 2024HotDog Warming Mattress + Return Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Temperature Management, LLC · DWJ System, Thermal Regulating
Cleared on Jun 29, 2023 as substantially equivalent to K220941 (Augustine Temperature Management, 2022) after a 92-day review. Its family tree reaches back 7 generations to 2002. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jun 29, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011859 (2002). 12 ancestors in all, the oldest K960167 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 6 generations backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- 5 generations backK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- 4 generations backK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
- 3 generations backK094056 Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
- 2 generations backK201779 HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · Recalled
- 1 generation backK220941 HotDog Temperature Management SystemAugustine Temperature Management · 2022 · Recalled
- This deviceK230866 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023
- Descendant · cites it directly · 0 of its ownK232627 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −6 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| −5 | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | Inditherm Medical | 2006 | — |
| −4 | K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 | Augustine Biomedical & Design, LLC | 2009 | — |
| −3 | K094056 | Hotdog Multi Function Controller | Augustine Biomedical & Design, LLC | 2010 | — |
| −2 | K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020 | 4 |
| −1 | K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022 | 4 |
| 0 (this device) | K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K220941 | HotDog Temperature Management SystemSummary page 4…Accessories (21 CFR § 878.4400) Common Name Warming Mattress + Return Electrode Predicate Device HotDog Temperature Management System (K220941) Reference Device HotDog Return Electrode Mattress (K210727) Related Submission Q-Submission (Q222939) Device Descriptio… | 2022 |
| † | K210727 | HotDog Warming Mattress + Return Electrode | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232627 | HotDog Warming Mattress + Return Electrode | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2024 | Class II | Z-1197-2025 | Device Design | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that… |
| Dec 16, 2024 | Class II | Z-1199-2025 | Device Design | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that… |
| Feb 15, 2024 | Class II | Z-1172-2025 | Device Design | Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . |
| Feb 15, 2024 | Class II | Z-1171-2025 | Device Design | Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K232627 (Augustine Temperature Management, LLC, 2024) has gone furthest, with 0 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. 2023, 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 HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other…
Read the full statement (128 words)
The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients.
The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.
The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230866: HotDog Warming Mattress + Return Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230866
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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