Coloplast A.S.: FDA clearances and approvals
Coloplast A.S. has 1 FDA 510(k) clearance (first 2026, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 20 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 20 |
Review time against the same product codes
Since 2017, Coloplast A.S.'s cleared 510(k)s took a median 20 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZD | Catheter, Straight | 1 | 1 |
Review panels
Most recent Coloplast A.S. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262045 | Luja Soft | EZD | 2026-07-07 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Coloplast A.S..
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 Coloplast A.S. have?
Coloplast A.S. has 1 FDA 510(k) clearance (first 2026, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Coloplast A.S.'s 510(k)s?
The median time from FDA receipt to decision across Coloplast A.S.'s cleared 510(k)s is 20 days.
What devices does Coloplast A.S. make?
Its most frequent FDA product codes are EZD (Catheter, Straight, 1).
Has Coloplast A.S. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coloplast A.S. Related entities may recall under other names.
Next steps
- See all 1 Coloplast A.S. clearances with predicates and recalls
- Run predicate analysis for product code EZD, Coloplast A.S.'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.