510(k) Report

FDA applicant

Alsius Corp.

Irvine, CA9 decisions2003–20086 recalls

FDA records 9 decisions for Alsius Corp. (Irvine, CA) from 2003 to 2008: 9 510(k) clearances. All are in product code NCX (System, Hypothermia, Intravenous, Cooling). Its devices cite 11 predicates, 5 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Alsius Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 32008: 1
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Alsius Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alsius Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NCXSystem, Hypothermia, Intravenous, Cooling9decisions

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 20035cite it
  • K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 20035cite it
  • K052443Icy Catheter, Model IC-3893AAlsius Corp. · 20052cite it
  • K060308Coolgard 3000Alsius Corp. · 20061cites it
  • K081936Solex Catheter, Model SL2593Alsius Corp. · 20081cites it
  • K070161Quattro Catheter Model IC4593Alsius Corp. · 20071cites it

What has FDA decided for it lately?

  • K081936Solex Catheter, Model SL2593Alsius Corp. · 2008
  • K072234Thermogard XP Thermal Regulation SystemAlsius Corp. · 2007
  • K070161Quattro Catheter Model IC4593Alsius Corp. · 2007
  • K063829Thermogard Thermal Regulation SystemAlsius Corp. · 2007
  • K060308Coolgard 3000Alsius Corp. · 2006
  • K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005
  • K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A; Fortius Catheter Kit…Alsius Corp. · 2005
  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 20034 recalls

All 9 as Alsius Corp. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K014241Alsius Cool Line Catheter, Model CL-2295AJan 1, 2007
  • K014241Alsius Cool Line Catheter, Model CL-2295AEJan 1, 2007
  • K014241Alsius CoolGard Temperature Regulation SystemNov 9, 2005
  • K014241Alsius CoolGard 3000 Temperature Regulation SystemJul 25, 2005
  • K014241Alsius CoolGard 3000 patient temperature regulation systemNov 10, 2004
  • K014241Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000Jun 21, 2004