Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Copan Italia Spa — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
414 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232565 | UriSponge™ | Copan Italia Spa | 2024-10-11 | 414 | 0 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024-04-25 | 262 | 0 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation Syste | Copan Italia Spa | 2022-12-16 | 344 | 0 |
| K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020-09-17 | 73 | 0 |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018-03-23 | 74 | 0 |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTE | Copan Italia Spa | 2015-04-10 | 252 | 0 |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Copan Italia Spa | 1997-08-20 | 51 | 0 |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Copan Italia Spa | 1997-08-20 | 51 | 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