Collamatrix Co., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Collamatrix Co., Inc.” (first 2006, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 159 days. 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 | 0 | — |
| 2013 | 1 | 1029 |
| 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
Review panels
Most recent Collamatrix Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100695 | COLLADENTAL BARRIER | NPL | 2013-01-03 | 1029 |
| K093351 | COLLAWOUND ART | FRO | 2010-06-16 | 232 |
| K090894 | COLLAWOUND WOUND DRESSING | KGN | 2009-06-25 | 86 |
| K071557 | COLLAWOUND HYDROGEL | FRO | 2008-02-08 | 246 |
| K070269 | MODIFICATION TO COLLAWOUND DRESSING | KGN | 2007-03-02 | 32 |
| K061474 | COLLAWOUND DRESSING | KGN | 2006-07-05 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Collamatrix Co., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Collamatrix Co., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Collamatrix Co., Inc.” (first 2006, latest 2013), across 3 product codes in 2 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 Collamatrix Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Collamatrix Co., Inc. is 159 days.
Which FDA product codes appear under Collamatrix Co., Inc.?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 3); FRO (Dressing, Wound, Drug, 2); NPL (Barrier, Animal Source, Intraoral, 1).
Next steps
- See all 6 Collamatrix Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Collamatrix Co., Inc.'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.