Innocoll Pharmaceuticals: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Innocoll Pharmaceuticals” (first 2006, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 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 | 1 | 139 |
| 2013 | 0 | — |
| 2014 | 1 | 188 |
| 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) | 6 | 6 |
Review panels
Most recent Innocoll Pharmaceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133290 | COLLACARE DENTAL | KGN | 2014-05-01 | 188 |
| K120339 | PROCOLL | KGN | 2012-06-21 | 139 |
| K100574 | COLLEXA | KGN | 2010-10-28 | 241 |
| K092805 | COLLAGEN SPONGE | KGN | 2010-02-16 | 158 |
| K081782 | COLLIEVA | KGN | 2008-09-30 | 99 |
| K061746 | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID | KGN | 2006-10-02 | 103 |
Recalls
openFDA lists no recalls under a recalling firm named Innocoll Pharmaceuticals.
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.
- Innocoll Pharmaceuticals, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innocoll Pharmaceuticals?
FDA lists 6 510(k) clearances under the applicant name “Innocoll Pharmaceuticals” (first 2006, latest 2014), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innocoll Pharmaceuticals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innocoll Pharmaceuticals is 148 days.
Which FDA product codes appear under Innocoll Pharmaceuticals?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 6).
Next steps
- See all 6 Innocoll Pharmaceuticals clearances with predicates and recalls
- Run predicate analysis for product code KGN, Innocoll Pharmaceuticals'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.