510(k) · Cleared
ClearedVitaheat Patient Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitaheat Medical, LLC · DWJ System, Thermal Regulating
Cleared on Oct 4, 2013 as substantially equivalent to K092807 (Augustine Biomedical & Design, LLC, 2009) after a 59-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Oct 4, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011859 (2002). 9 ancestors in all, the oldest K960167 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 3 generations backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- 2 generations backK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- 1 generation backK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
- This deviceK132454 Vitaheat Patient Warming SystemVitaheat Medical, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −3 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K132454 | Vitaheat Patient Warming System | Vitaheat Medical, LLC | 2013 | — |
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 |
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 |
|---|---|---|---|
| * | K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Summary page 5…VITA HEAT mn u Ur a I Predicate Device Hot Dog Patient Warming Mattress System by Augustine Biomedical & Design LLC. (K092807). Summary of Technical Characteristics The VITAHEATTM Patient Warming System was compared to the predicate device in areas of… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K092807.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 VITAHEAT Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The VITAHEAT Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia.
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/K132454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132454: Vitaheat 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/K132454
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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