510(k) · Cleared
Recalled · Class II · 2025Allon 2001 Version 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mtre Advanced Technology, Ltd. · DWJ System, Thermal Regulating
Cleared on Feb 10, 2003 as substantially equivalent to K003349 (Mtre Advanced Technology, Ltd., 2000) after a 56-day review. Its family tree reaches back 1 generation to 2000. 17 later devices descend from it. It has been recalled once.
- Decided
- Feb 10, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003349 (2000). 17 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
- This deviceK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003
- Descendant · cites it directly · 16 of its ownK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K083662CriticoolMtre Advanced Technology, Ltd. · 2009 · cites it directly16descendants
- K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011 · 2 generations on9descendants
- K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc. · 2014 · 3 generations on4descendants
- K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. · 2010 · 2 generations on4descendants
- K152266Altrix Precision Temperature Management SystemStryker Medical · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | 2000 | — |
| 0 (this device) | K024128 | Allon 2001 Version 5 | Mtre Advanced Technology, Ltd. | 2003 | — |
| +1 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| +2 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | — |
| +3 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS… | Medivance, Inc. | 2014 | 6 |
| +2 | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | Cincinnati Sub-Zero Products, Inc. | 2010 | 6 |
| +3 | K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K003349 | Allon 2001 ModifiedSummary page 2…is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under KO01 546, K992356 and K003349. Indication for use-- The Allon 2001 version 5 is intended to maintain pre-set body… | 2000 |
| * | — | Cincinnati Subzero - Blanketrol Named without a submission number | |
| † | K001546 | ALLON 2001 | 2000 |
| † | K992356 | Unnamed device |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2025 | Class II | Z-1966-2025 | Device Design | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Allon 2001 version 5 is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024128: Allon 2001 Version 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024128
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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