Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Alsius Corp. — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

41 daysmedian FDA review time

583 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K081936	SOLEX CATHETER, MODEL SL2593	Alsius Corp.	2008-08-13	37	0
K072234	THERMOGARD XP THERMAL REGULATION SYSTEM	Alsius Corp.	2007-08-23	13	0
K070161	QUATTRO CATHETER MODEL IC4593	Alsius Corp.	2007-02-15	29	0
K063829	THERMOGARD THERMAL REGULATION SYSTEM	Alsius Corp.	2007-01-22	27	0
K060308	COOLGARD 3000	Alsius Corp.	2006-04-26	78	0
K052443	ICY CATHETER, MODEL IC-3893A	Alsius Corp.	2005-10-17	41	0
K051912	COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHE	Alsius Corp.	2005-10-11	89	0
K030421	ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM	Alsius Corp.	2003-10-23	255	4
K014241	COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-	Alsius Corp.	2003-08-01	583	6

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda