510(k) · Cleared
ClearedInditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inditherm Medical · DWJ System, Thermal Regulating
Cleared on Apr 27, 2006 as substantially equivalent to K011859 (Klimamed Technologie Medizingerate GmbH, 2002) and 1 other predicate after a 330-day review. Its family tree reaches back 2 generations to 2002. 9 later devices descend from it.
- Decided
- Apr 27, 2006
- Review
- 330 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011859 (2002). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 1 generation backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- This deviceK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- Descendant · cites it directly · 6 of its ownK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
- Descendant · 2 generations on · 4 of its ownK094056 Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
- Descendant · 3 generations on · 3 of its ownK201779 HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · Recalled
- Descendant · 4 generations on · 2 of its ownK220941 HotDog Temperature Management SystemAugustine Temperature Management · 2022 · Recalled
- Descendant · 5 generations on · 1 of its ownK230866 HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 2009 · cites it directly6descendants
- K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010 · 2 generations on4descendants
- K201779HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · 3 generations on3descendants
- K220941HotDog Temperature Management SystemAugustine Temperature Management · 2022 · 4 generations on2descendants
- K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −1 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| 0 (this device) | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | Inditherm Medical | 2006 | — |
| +1 | 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 | — |
| +3 | K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020 | 4 |
| +4 | K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022 | 4 |
| +5 | K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K011859 | Klimamed Thermal Mat & Controller 95 and 55 WattsSummary page 1…Model numbers: MECUI, OTMI, OTM2, GTMl, PTMI, OTB, RBI Common Name: Thermal Regulating System Equivalence to: Klimamed Thermal Mat and Controller (K011859) Klimamed Thermal Blanket and Controller (K031728) Description: The Inditherm Patient Warming System c… | 2002 |
| * | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer…Summary page 1…ommon Name: Thermal Regulating System Equivalence to: Klimamed Thermal Mat and Controller (K011859) Klimamed Thermal Blanket and Controller (K031728) Description: The Inditherm Patient Warming System consists of a precision temperature control unit t… | 2004 |
What descends from it? (9)
3 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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092807 (Augustine Biomedical & Design, LLC, 2009) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K011859.
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?
Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department, the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. The mattress includes a pressure-relieving pad.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051419: Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051419
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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