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

Copan Diagnostics, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
413 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSCopan Diagnostics, Inc.2006-06-23440
K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMCopan Diagnostics, Inc.2004-12-07400
K001780COPAN VIRAL TRANSYSTEMCopan Diagnostics, Inc.2001-07-314130
K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.1999-11-09481
K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMCopan Diagnostics, Inc.1995-03-10730
K946286COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUMCopan Diagnostics, Inc.1995-03-10730
K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUMCopan Diagnostics, Inc.1995-03-10730
K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMCopan Diagnostics, Inc.1995-03-10731
K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALCopan Diagnostics, Inc.1995-03-10730
K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALCopan Diagnostics, Inc.1995-03-10730

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