510(k) · Cleared
ClearedTru-5000 Thermal Recovery Radiant Heating Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enthermics Medical Systems, Inc. · DWJ System, Thermal Regulating
Cleared on Apr 22, 1997 as substantially equivalent to K873745 (Augustine Medical, Inc., 1987) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 22, 1997
- Review
- 217 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873745 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK873745 Bair Hugger (TM) - Patient Warming SystemAugustine Medical, Inc. · 1987
- This deviceK963731 Tru-5000 Thermal Recovery Radiant Heating UnitEnthermics Medical Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873745 | Bair Hugger (TM) - Patient Warming System | Augustine Medical, Inc. | 1987 | — |
| 0 (this device) | K963731 | Tru-5000 Thermal Recovery Radiant Heating Unit | Enthermics Medical Systems, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K873745 | Bair Hugger (TM) - Patient Warming SystemSummary page 2…7 The ENTHERMICS TRU-5000 Thermal Recovery Radiant Heating Unit is identical in function to the Augustine Medical Bair Hugger™ Convective Warming System (K873745) and the Marquest Temp Marq™ Convective Warming System (K904690) in that it offers a rapid, accurate, reproducible means of admin… | 1987 |
| * | K904690 | Temp Marq (TM) Convective Warming SystemSummary page 2…nt Heating Unit is identical in function to the Augustine Medical Bair Hugger™ Convective Warming System (K873745) and the Marquest Temp Marq™ Convective Warming System (K904690) in that it offers a rapid, accurate, reproducible means of administering external heat to adult hypothermia patients in a clinic… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K873745.
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?
The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963731: Tru-5000 Thermal Recovery Radiant Heating Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963731
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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