Copan Italia Spa: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Copan Italia Spa” (first 1997, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 163 days. Since 2017 the median was 262 days, against 269 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 252 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 74 |
| 2019 | 0 | — |
| 2020 | 1 | 73 |
| 2021 | 0 | — |
| 2022 | 1 | 344 |
| 2023 | 0 | — |
| 2024 | 2 | 338 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Copan Italia Spa took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 269 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | 5 | 5 |
| JSL | Culture Media, Anaerobic Transport | 2 | 2 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | 1 | 1 |
Review panels
- Microbiology (8)
Most recent Copan Italia Spa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232565 | UriSponge | JSM | 2024-10-11 | 414 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | JSM | 2024-04-25 | 262 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | JSM | 2022-12-16 | 344 |
| K201849 | eNAT molecular collection and preservation medium | QBD | 2020-09-17 | 73 |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | JSM | 2018-03-23 | 74 |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | JSM | 2015-04-10 | 252 |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | JSL | 1997-08-20 | 51 |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | JSL | 1997-08-20 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Copan Italia Spa.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Copan Diagnostics, Inc. (10 510(k)s)
- Copan Wasp Srl (5 510(k)s)
- Copan Flock Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Copan Italia Spa?
FDA lists 8 510(k) clearances under the applicant name “Copan Italia Spa” (first 1997, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Copan Italia Spa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Copan Italia Spa is 163 days. Since 2017: 262 days, versus 269 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Copan Italia Spa?
The most frequent FDA product codes under this applicant name are JSM (Culture Media, Non-Propagating Transport, 5); JSL (Culture Media, Anaerobic Transport, 2); QBD (Microbial Nucleic Acid Storage And Stabilization Device, 1).
Next steps
- See all 8 Copan Italia Spa clearances with predicates and recalls
- Run predicate analysis for product code JSM, Copan Italia Spa's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.