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

NCX — Predicate Candidate Screening

26 FDA 510(k) clearances under this product code; the 50 most recent screened below.

129 daysmedian FDA review time

309 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K223746	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr	Zoll Circulation, Inc.	2023-01-13	30	0
K220008	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr	Zoll Circulation, Inc.	2022-06-02	149	0
K213031	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intr	Zoll Circulation, Inc.	2021-12-20	90	0
K152946	TEMPEDY	Seiratherm GmbH	2016-09-15	345	0
K153162	Hypocore	Novocor Medical Systems, Inc.	2016-05-24	204	0
K153226	Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up	Zoll Circulation, Inc.	2016-03-24	139	0
K150046	Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Ca	Zoll Circulation, Inc.	2015-10-30	291	0
K141139	SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER	Zoll Circulation	2014-10-03	154	0
K101987	COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3	Zoll Circulation	2010-10-12	90	0
K080908	INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM	Innercool Therapies, Inc.- A Delaware Corporation	2008-10-17	199	1
K081936	SOLEX CATHETER, MODEL SL2593	Alsius Corp.	2008-08-13	37	0
K080899	ARCTIC BLAST INTRAVENOUS FLUID CHILLER	Medivance, Inc.	2008-08-07	129	0
K072234	THERMOGARD XP THERMAL REGULATION SYSTEM	Alsius Corp.	2007-08-23	13	0
K071358	REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM	Radiant Medical	2007-06-01	17	0
K071008	REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM	Radiant Medical	2007-05-09	30	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
K063405	REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM	Radiant Medical	2007-01-08	60	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
K033623	CELSIUS CONTROL SYSTEM	Innercool Therapies, Inc.	2004-05-21	185	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
K022366	CELSIUS CONTROL SYSTEM	Innercool Therapies	2003-01-27	189	0
K012512	SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM	Radiant Medical	2002-06-11	309	0

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