510(k) · Cleared
ClearedSolex Catheter, Model SL2593
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alsius Corp. · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Aug 13, 2008 as substantially equivalent to K030421 (Alsius Corp., 2003) after a 37-day review. Its family tree reaches back 4 generations to 1981. 5 later devices descend from it.
- Decided
- Aug 13, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K811742 (1981). 15 ancestors in all, the oldest K811743 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 3 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 2 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 1 generation backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- This deviceK081936 Solex Catheter, Model SL2593Alsius Corp. · 2008
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 2 of its ownK213031 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK220008 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK223746 Solex 7 Intravascular Heat Exchange Catheter, Cool Line…Zoll Circulation, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K141139Solex Intravascular Heat Exchange CatheterZoll Circulation · 2014 · cites it directly4descendants
- K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc. · 2016 · 2 generations on3descendants
- K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2021 · 3 generations on2descendants
- K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2022 · 4 generations on1descendant
- K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −3 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −1 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| 0 (this device) | K081936 | Solex Catheter, Model SL2593 | Alsius Corp. | 2008 | — |
| +1 | 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 |
| +3 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2021 | — |
| +4 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2022 | — |
| +4 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat… | Zoll Circulation, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 NCX? 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 NCX device
- #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 10.9 · 9 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 |
|---|---|---|---|
| * | K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemSummary page 1…Venous Catheter (short term) and Thermal Regulating System. Classification Name: 21 CFR 870.5900 System, hypothermia, intravenous, cooling Predicate Device: K030421 Alsius Fortius Catheter Kit Model FR-5093 Decision Date 10/23/2003 Decision Substantially equivalent… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141139 | Solex Intravascular Heat Exchange Catheter | 2014 | 4 |
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 27 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K141139 (Zoll Circulation, 2014) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K030421.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NCX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NCX
204in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NCX
28in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NCX
273in 2025
MAUDE reports naming product code NCX, 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 | 6 | 28 | 2 | 4 |
| 2008 | 3 | 129 | 0 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 1 | — | 1 | 41 |
| 2015 | 1 | — | 0 | 32 |
| 2016 | 3 | 204 | 0 | 311 |
| 2017 | 0 | — | 0 | 450 |
| 2018 | 0 | — | 0 | 509 |
| 2019 | 0 | — | 0 | 436 |
| 2020 | 0 | — | 0 | 415 |
| 2021 | 1 | — | 28 | 461 |
| 2022 | 1 | — | 0 | 511 |
| 2023 | 1 | — | 0 | 373 |
| 2024 | 0 | — | 0 | 343 |
| 2025 | 0 | — | 0 | 273 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Solex Catheter Model SL2593, connected to an Alsius External Thermal Regulation System, is indicated for use:
* in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and
* to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081936: Solex Catheter, Model SL2593.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081936
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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