Coloplast Corp.: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “Coloplast Corp.” (first 1985, latest 2025), plus 3 PMA decisions, across 28 product codes in 4 review panels. Median 510(k) review time under this name: 101 days. Since 2017 the median was 190 days, against 122 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 | 3 | 101 |
| 2013 | 1 | 30 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 112 |
| 2017 | 4 | 260 |
| 2018 | 7 | 62 |
| 2019 | 1 | 121 |
| 2020 | 5 | 228 |
| 2021 | 1 | 269 |
| 2022 | 7 | 252 |
| 2023 | 4 | 154 |
| 2024 | 7 | 137 |
| 2025 | 3 | 77 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Coloplast Corp. took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZD | Catheter, Straight | 12 | 12 |
| GBM | Catheter, Urethral | 10 | 10 |
| FAD | Stent, Ureteral | 7 | 7 |
| FRO | Dressing, Wound, Drug | 6 | 6 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 3 | 3 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 3 | 3 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 3 | 3 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 3 | 3 |
| EYB | Catheter, Ureteral, Gastro-Urology | 2 | 2 |
| EZN | Dilator, Catheter, Ureteral | 2 | 2 |
Plus 18 more product codes.
Review panels
- Gastroenterology and Urology (46)
- General and Plastic Surgery (20)
- Obstetrics and Gynecology (5)
- Dental (1)
Most recent Coloplast Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252140 | Heylo System | EXB | 2025-10-06 | 90 |
| K251116 | Luja Coudé | EZD | 2025-06-27 | 77 |
| K250270 | Luja Set | EZD | 2025-04-17 | 77 |
| K242049 | SureCath Set | EZD | 2024-11-26 | 137 |
| K241210 | Luja Coude | EZD | 2024-11-21 | 205 |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | FED | 2024-11-12 | 111 |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | PAH | 2024-10-18 | 59 |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | EZD | 2024-07-26 | 102 |
| K233411 | Folysil Silicone Catheter | EZL | 2024-04-15 | 192 |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | FRO | 2024-03-22 | 266 |
59 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020003 | PMA | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS | 2002-07-19 |
| P000006 | PMA | TITAN INFLATABLE PENILE PROSTHESIS | 2000-07-14 |
| N16420 | PMA | MENTOR POLYTEF PASTE FOR INJECTION | 1972-01-20 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-11-12.
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.
- Coloplast A/S (71 510(k)s)
- Coloplast Manufacturing Us, LLC (4 510(k)s)
- Coloplast A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coloplast Corp.?
FDA lists 69 510(k) clearances under the applicant name “Coloplast Corp.” (first 1985, latest 2025), plus 3 PMA decisions, across 28 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coloplast Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coloplast Corp. is 101 days. Since 2017: 190 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Coloplast Corp.?
The most frequent FDA product codes under this applicant name are EZD (Catheter, Straight, 12); GBM (Catheter, Urethral, 10); FAD (Stent, Ureteral, 7).
Next steps
- See all 69 Coloplast Corp. clearances with predicates and recalls
- Run predicate analysis for product code EZD, Coloplast Corp.'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.