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

Codan US Corp. — Predicate Candidate Screening

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

79 daysmedian FDA review time

224 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112268	CODAN SAFEFEED ENTERAL FEEDING RESERVOIR	Codan US Corp.	2012-03-19	224	0
K042693	IV ADMINISTRATION SET B400 SP	Codan US Corp.	2004-10-21	21	0
K033301	IV ADMINISTRATION AND CONNECT SETS	Codan US Corp.	2004-03-04	142	1
K021480	EXTENSION SET LIGHT-SAFE, MODEL BC565	Codan US Corp.	2002-06-27	50	0
K013714	CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP	Codan US Corp.	2002-03-28	140	0
K001872	I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B41	Codan US Corp.	2000-09-07	79	0
K990711	CODAN CHEMOSPIKE	Codan US Corp.	1999-04-13	40	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