Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innocoll Pharmaceuticals — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
241 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133290 | COLLACARE DENTAL | Innocoll Pharmaceuticals | 2014-05-01 | 188 | 0 |
| K120339 | PROCOLL | Innocoll Pharmaceuticals | 2012-06-21 | 139 | 0 |
| K100574 | COLLEXA | Innocoll Pharmaceuticals | 2010-10-28 | 241 | 0 |
| K092805 | COLLAGEN SPONGE | Innocoll Pharmaceuticals | 2010-02-16 | 158 | 0 |
| K081782 | COLLIEVA | Innocoll Pharmaceuticals | 2008-09-30 | 99 | 0 |
| K061746 | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID | Innocoll Pharmaceuticals | 2006-10-02 | 103 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda