Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adri — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
539 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041268 | SILVERSITE OR CALGITROL | Adri | 2004-09-20 | 131 | 0 |
| K011618 | CALGITROL AG SILVER ALGINATE WOUND DRESSING | Adri | 2002-11-15 | 539 | 0 |
| K000054 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN | Adri | 2000-03-13 | 66 | 0 |
| K963656 | FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING | Adri | 1996-11-12 | 61 | 0 |
| K940404 | ALGINATE FIBER TOPICAL WOUND DRESSING | Adri | 1994-05-04 | 97 | 0 |
| K870383 | ALGINATE WOOL FIBER | Adri | 1987-04-30 | 90 | 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