Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cornelia Damsky, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001322 | PERFORMER 30 HPS | Cornelia Damsky, Inc. | 2000-06-30 | 65 | 0 |
| K946321 | BIOSTRIP STERILE WOUND CLOSURE STRIP | Cornelia Damsky, Inc. | 1995-01-12 | 15 | 0 |
| K852858 | STRETCH BANDAGE | Cornelia Damsky, Inc. | 1985-07-26 | 21 | 0 |
| K852857 | 4 X 4' GAUZE PAD | Cornelia Damsky, Inc. | 1985-07-26 | 21 | 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