Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dermatec, 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) |
|---|---|---|---|---|---|
| K863580 | DERMATEC TRANSPARENT FILM DRESSING | Dermatec, Inc. | 1986-12-31 | 125 | 0 |
| K863578 | DERMATEC ZONE TRANSPARENT DRESSING | Dermatec, Inc. | 1986-11-25 | 89 | 0 |
| K863379 | DERMATEC BURN PADS | Dermatec, Inc. | 1986-09-26 | 23 | 0 |
| K833638 | DERMATEX STERILE FINGER BANDAGE | Dermatec, Inc. | 1983-12-27 | 71 | 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