510(k) · Cleared
ClearedAllon 2001 Modified
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 Nov 13, 2000 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.
- Decided
- Nov 13, 2000
- Review
- 18 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 4 citing it directly.
- This deviceK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
- Descendant · cites it directly · 17 of its ownK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 16 of its ownK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- Descendant · cites it directly · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
- Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- Descendant · cites it directly · 9 of its ownK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K024128Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · cites it directly17descendants
- K083662CriticoolMtre Advanced Technology, Ltd. · 2009 · 2 generations on16descendants
- K022366Celsius Control SystemInnercool Therapies · 2003 · cites it directly16descendants
- K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
- K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | 2000 | — |
| +1 | K024128 | Allon 2001 Version 5 | Mtre Advanced Technology, Ltd. | 2003 | 1 |
| +2 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| +1 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| +1 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 364 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?
- Of its descendants, K024128 (Mtre Advanced Technology, Ltd., 2003) has gone furthest, with 17 descendants 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.
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 | — |
https://510kreport.com/device/K003349 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003349: Allon 2001 Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003349
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026