Copan Wasp Srl: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Copan Wasp Srl” (first 2021, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 222 days, against 94 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 |
|---|---|---|
| 2021 | 1 | 775 |
| 2022 | 1 | 222 |
| 2023 | 2 | 130 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 251 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Copan Wasp Srl took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 2 | 2 |
| QQV | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | 2 | 2 |
| PPU | Microbial Colony Image Assessment System | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Copan Wasp Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251511 | PhenoMATRIX | PPU | 2026-01-22 | 251 |
| K232756 | Colibrí | LON | 2023-12-27 | 110 |
| K223245 | Colibrí | QQV | 2023-03-20 | 151 |
| K220546 | Colibrí System | LON | 2022-10-05 | 222 |
| K193138 | Colibri System | QQV | 2021-12-27 | 775 |
Recalls
openFDA lists no recalls under a recalling firm named Copan Wasp Srl.
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 Italia Spa (8 510(k)s)
- Copan Flock Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Copan Wasp Srl?
FDA lists 5 510(k) clearances under the applicant name “Copan Wasp Srl” (first 2021, latest 2026), 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 Wasp Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Copan Wasp Srl is 222 days. Since 2017: 222 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Copan Wasp Srl?
The most frequent FDA product codes under this applicant name are LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 2); QQV (Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry, 2); PPU (Microbial Colony Image Assessment System, 1).
Next steps
- See all 5 Copan Wasp Srl clearances with predicates and recalls
- Run predicate analysis for product code LON, Copan Wasp Srl'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.