510(k) · Cleared
ClearedIcy Catheter, Model IC-3893A
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 Oct 17, 2005 as substantially equivalent to K030421 (Alsius Corp., 2003) after a 41-day review. Its family tree reaches back 4 generations to 1981. 8 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 41 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). 8 later devices descend from it, 2 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 deviceK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- Descendant · cites it directly · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
- Descendant · cites it directly · 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 · 2 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · cites it directly7descendants
- K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · cites it directly6descendants
- 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 · 2 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 |
|---|---|---|---|---|---|
| −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) | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| +1 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
| +1 | 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 |
| +2 | 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 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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…ame: Central Venous Catheter (short term) and Thermal Regulating System. Classification Name: 21 CFR 870.5900 System, hypothermia, intravenous, cooling Predicate Device: K030421 Alsius IcyTM Catheter Kit Model IC-3585A Decision Date 10/23/2003 Decision Substantially equivalent (SE) Indicati… | 2003 |
What descends from it? (8)
2 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K070161 (Alsius Corp., 2007) has gone furthest, with 7 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.
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 Icy™ Catheter Model IC-3893A, connected to the COOLGARD 3000/Alsius Catheter 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/K052443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052443: Icy Catheter, Model IC-3893A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052443
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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