510(k) · Cleared
Recalled · Class II · 2024HotDog Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augustine Temperature Management · DWJ System, Thermal Regulating
Cleared on Sep 23, 2022 as substantially equivalent to K201779 (Augustine Temperature Management, 2020) after a 176-day review. Its family tree reaches back 6 generations to 2002. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 23, 2022
- Review
- 176 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011859 (2002). 11 ancestors in all, the oldest K960167 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 5 generations backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- 4 generations backK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- 3 generations backK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
- 2 generations backK094056 Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
- 1 generation backK201779 HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · Recalled
- This deviceK220941 HotDog Temperature Management SystemAugustine Temperature Management · 2022
- Descendant · cites it directly · 1 of its ownK230866 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK232627 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −5 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| −4 | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | Inditherm Medical | 2006 | — |
| −3 | K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103 | Augustine Biomedical & Design, LLC | 2009 | — |
| −2 | K094056 | Hotdog Multi Function Controller | Augustine Biomedical & Design, LLC | 2010 | — |
| −1 | K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020 | 4 |
| 0 (this device) | K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022 | — |
| +1 | K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023 | 4 |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K201779 | HotDog Temperature Management ControllerSummary page 4…DWJ - Thermal Regulating System (21 CFR §870.5900) Common Name Thermal Regulating System Predicate Device HotDog Temperature Management Controller - K201779 Reference Device AltrixTM Precision Temperature Management System - K180834 Device Description The HotDog Temperature Man… | 2020 |
| † | K180834 | Altrix Precision Temperature Management System | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230866 | HotDog Warming Mattress + Return Electrode | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2024 | Class II | Z-0700-2025 | Device Design | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST". |
| Dec 4, 2024 | Class II | Z-0701-2025 | Device Design | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST". |
| Dec 4, 2024 | Class II | Z-0702-2025 | Device Design | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST". |
| Mar 14, 2022 | Class II | Z-0839-2025 | Device Design | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K230866 (Augustine Temperature Management, LLC, 2023) has gone furthest, with 1 descendant 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. 2022, 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 and pediatric 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220941: HotDog Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220941
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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