Coloplast A/S: FDA clearances and approvals
Coloplast A/S has 71 FDA 510(k) clearances (first 1983, latest 2023), across 29 product codes in 3 review panels. Median 510(k) review time: 76 days. Since 2017 its median was 116 days, against 162 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 103 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 8 | 126 |
| 2013 | 3 | 83 |
| 2014 | 2 | 84 |
| 2015 | 4 | 81 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 76 |
| 2019 | 0 | — |
| 2020 | 1 | 256 |
| 2021 | 0 | — |
| 2022 | 1 | 116 |
| 2023 | 1 | 232 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Coloplast A/S's cleared 510(k)s took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EXB | Collector, Ostomy | 11 | 11 |
| FRO | Dressing, Wound, Drug | 6 | 6 |
| KMF | Bandage, Liquid | 5 | 5 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 | 5 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 4 | 4 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | 4 | 4 |
| GBM | Catheter, Urethral | 3 | 3 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 3 | 3 |
| EXD | Irrigator, Ostomy | 2 | 2 |
Plus 19 more product codes.
Review panels
Most recent Coloplast A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221874 | Altis Single Incision Sling System | PAH | 2023-02-15 | 232 |
| K220420 | Saffron Fixation System | PBQ | 2022-06-10 | 116 |
| K191536 | Biatain Silicone Ag | FRO | 2020-02-21 | 256 |
| K181811 | ReTrace Ureteral Access Sheath | FED | 2018-09-07 | 63 |
| K173527 | Digitex Delivery Device | PWI | 2018-02-12 | 90 |
| K140310 | Peristeen Anal Irrigation System | KNT | 2015-09-03 | 573 |
| K150935 | SpeediCath Compact Eve | GBM | 2015-07-02 | 86 |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | OCY | 2015-05-27 | 51 |
| K143182 | Speedicath Compact Male | GBM | 2015-01-20 | 76 |
| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | FED | 2014-07-24 | 142 |
61 earlier clearances. See the full list in Caduvo.
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.
Device clinical trials
Coloplast A/S is the industry lead sponsor of 103 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07376421: Clinical Investigation Exploring a Newly Developed Ostomy Baseplate (Completed, started 2026-01-24)
- NCT07126327: Peristeen Light Explorative Clinical Investigation (Recruiting, started 2025-11-10)
- NCT07316530: Clinical Investigation Exploring a Newly Developed Ostomy Baseplate. (Completed, started 2025-11-03)
- NCT06985888: New Coating for Urinary Intermittent Catheters (Completed, started 2025-05-06)
- NCT06965140: CP376 OCT Exploratory Skin Study (Completed, started 2025-04-07)
Frequently asked questions
How many FDA 510(k) clearances does Coloplast A/S have?
Coloplast A/S has 71 FDA 510(k) clearances (first 1983, latest 2023), across 29 product codes in 3 review panels.
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 76 days. Since 2017: 116 days, versus 162 days for all cleared 510(k)s in the same product codes.
What devices does Coloplast A/S make?
Its most frequent FDA product codes are EXB (Collector, Ostomy, 11); FRO (Dressing, Wound, Drug, 6); KMF (Bandage, Liquid, 5).
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 71 Coloplast A/S clearances with predicates and recalls
- Run predicate analysis for product code EXB, 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.