Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dermaphylyx, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
90 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992302 | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS | Dermaphylyx, Inc. | 1999-09-14 | 68 | 0 |
| K991920 | DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING | Dermaphylyx, Inc. | 1999-08-12 | 66 | 0 |
| K991933 | DERMAPHYLYX FOAM ISLAND DRESSING | Dermaphylyx, Inc. | 1999-07-30 | 52 | 0 |
| K991609 | DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING | Dermaphylyx, Inc. | 1999-07-20 | 71 | 0 |
| K991608 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | 1999-07-20 | 71 | 0 |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | 1999-06-28 | 90 | 0 |
| K990875 | DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESS | Dermaphylyx, Inc. | 1999-05-27 | 72 | 0 |
| K990891 | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOI | Dermaphylyx, Inc. | 1999-05-27 | 71 | 0 |
| K990438 | DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEA | Dermaphylyx, Inc. | 1999-03-25 | 42 | 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