Kerecis Limited: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Kerecis Limited” (first 2013, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 150 days. Since 2017 the median was 150 days, against 171 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 |
|---|---|---|
| 2013 | 1 | 85 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 273 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 128 |
| 2020 | 1 | 420 |
| 2021 | 1 | 250 |
| 2022 | 1 | 272 |
| 2023 | 0 | — |
| 2024 | 1 | 124 |
| 2025 | 3 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kerecis Limited took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 5 | 5 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | 2 | 2 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 | 1 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 1 | 1 |
Review panels
- General and Plastic Surgery (8)
- Dental (1)
- Orthopedic (1)
Most recent Kerecis Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | KGN | 2025-07-16 | 30 |
| K251844 | Kerecis SurgiBind (50241) | OXH | 2025-07-15 | 29 |
| K243843 | Tendon Protect (50242) | OWY | 2025-06-04 | 173 |
| K241080 | Kerecis Parvus (50207) | KGN | 2024-08-21 | 124 |
| K213231 | Kerecis Silicone | KGN | 2022-06-29 | 272 |
| K202430 | Kerecis Reconstruct | OXH | 2021-05-02 | 250 |
| K192612 | Kerecis Gingiva Graft | NPL | 2020-11-13 | 420 |
| K190528 | MariGen Wound Extra | KGN | 2019-07-10 | 128 |
| K153364 | Kerecis SecureMesh | OXE | 2016-08-19 | 273 |
| K132343 | MARIGEN WOUND DRESSING | KGN | 2013-10-23 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Kerecis Limited.
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.
- Kerecis (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kerecis Limited?
FDA lists 10 510(k) clearances under the applicant name “Kerecis Limited” (first 2013, latest 2025), across 5 product codes in 3 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 Kerecis Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kerecis Limited is 150 days. Since 2017: 150 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kerecis Limited?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 5); OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery, 2); NPL (Barrier, Animal Source, Intraoral, 1).
Next steps
- See all 10 Kerecis Limited clearances with predicates and recalls
- Run predicate analysis for product code KGN, Kerecis Limited'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.