Codan US Corp.: FDA clearances and approvals
Codan US Corp. has 7 FDA 510(k) clearances (first 1999, latest 2012), across 3 product codes in 2 review panels. Median 510(k) review time: 79 days. openFDA lists 2 product recalls by a recalling firm named Codan US Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 224 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 5 | 5 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
Most recent Codan US Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112268 | CODAN SAFEFEED ENTERAL FEEDING RESERVOIR | KNT | 2012-03-19 | 224 |
| K042693 | IV ADMINISTRATION SET B400 SP | FPA | 2004-10-21 | 21 |
| K033301 | IV ADMINISTRATION AND CONNECT SETS | FPA | 2004-03-04 | 142 |
| K021480 | EXTENSION SET LIGHT-SAFE, MODEL BC565 | FPA | 2002-06-27 | 50 |
| K013714 | CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP | FPA | 2002-03-28 | 140 |
| K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | 2000-09-07 | 79 |
| K990711 | CODAN CHEMOSPIKE | LHI | 1999-04-13 | 40 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-09-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Codan US Corp. have?
Codan US Corp. has 7 FDA 510(k) clearances (first 1999, latest 2012), across 3 product codes in 2 review panels.
How long does FDA take to clear Codan US Corp.'s 510(k)s?
The median time from FDA receipt to decision across Codan US Corp.'s cleared 510(k)s is 79 days.
What devices does Codan US Corp. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 5); KNT (Tubes, Gastrointestinal (And Accessories), 1); LHI (Set, I.V. Fluid Transfer, 1).
Has Codan US Corp. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Codan US Corp; the most recent began 2019-09-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Codan US Corp. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Codan US Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.