510(k) · Cleared
ClearedALLON 2001
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 Jun 8, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jun 8, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK001546 ALLON 2001Mtre Advanced Technology, Ltd. · 2000
- Descendant · cites it directly · 11 of its ownK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- Descendant · 2 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK141139 Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014
- Descendant · 2 generations on · 3 of its ownK153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003 · cites it directly11descendants
- K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 2 generations on6descendants
- K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · 2 generations on4descendants
- K141139Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014 · 3 generations on4descendants
- K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001546 | ALLON 2001 | Mtre Advanced Technology, Ltd. | 2000 | — |
| +1 | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D | Alsius Corp. | 2003 | 6 |
| +2 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| +2 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | 21 |
| +3 | K141139 | Solex Intravascular Heat Exchange Catheter | Zoll Circulation | 2014 | — |
| +2 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (13)
See all 132 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, K014241 (Alsius Corp., 2003) has gone furthest, with 11 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/K001546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001546: ALLON 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001546
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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