Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dermarx Corp. — 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) |
|---|---|---|---|---|---|
| K972336 | DERMAMEND HYDROGEL GAUZE DRESSING | Dermarx Corp. | 1997-07-29 | 36 | 0 |
| K970600 | DERMAMEND FOAM ISLAND DRESSING | Dermarx Corp. | 1997-05-08 | 79 | 0 |
| K962089 | DERMAMEND GEL | Dermarx Corp. | 1996-11-05 | 160 | 0 |
| K951561 | DYNASORB | Dermarx Corp. | 1995-09-01 | 149 | 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