Atlas FDA

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

Copan Wasp Srl — Predicate Candidate Screening

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

222 daysmedian FDA review time
775 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251511PhenoMATRIXCopan Wasp Srl2026-01-222510
K232756ColibríCopan Wasp Srl2023-12-271100
K223245ColibríCopan Wasp Srl2023-03-201510
K220546Colibrí SystemCopan Wasp Srl2022-10-052220
K193138Colibri SystemCopan Wasp Srl2021-12-277750

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