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

Avecor Cardiovascular, Inc. — Predicate Candidate Screening

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

169 daysmedian FDA review time

302 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K973760	AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SU	Avecor Cardiovascular, Inc.	1998-02-18	139	2
K964017	AFFINITY BLOOD PUMP SYSTEM	Avecor Cardiovascular, Inc.	1997-08-05	302	0
K971105	MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM	Avecor Cardiovascular, Inc.	1997-07-11	107	0
K952532	AFFINITY ARTERIAL BLOOD FILTER	Avecor Cardiovascular, Inc.	1995-10-06	127	0
K940126	AVECOR PRE-BYPASS FILTER	Avecor Cardiovascular, Inc.	1994-06-28	169	0
K936003	AFFINITY CVR	Avecor Cardiovascular, Inc.	1994-06-20	186	2
K935717	AFFINITY VENOUS RESERVIOR BAG	Avecor Cardiovascular, Inc.	1994-05-10	161	0
K932252	AFFINITY HOLLOW FIBER OXYGENATOR	Avecor Cardiovascular, Inc.	1993-11-19	177	0
K924529	SIGNATURE(TM) CUSTOM TUBING PACK	Avecor Cardiovascular, Inc.	1993-06-23	288	2

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