Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Selomas, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
111 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861215 | GAUZE SPONGES USP TYPE VII | Selomas, Inc. | 1986-04-17 | 17 | 0 |
| K821258 | SELOPOR | Selomas, Inc. | 1982-08-19 | 111 | 0 |
| K821259 | VITASAN | Selomas, Inc. | 1982-06-23 | 54 | 0 |
| K821260 | VITOFIT | Selomas, Inc. | 1982-06-23 | 54 | 0 |
| K821490 | SILKAFIX ADHESIVE PLASTER | Selomas, Inc. | 1982-06-02 | 15 | 0 |
| K821257 | SELOFIX | Selomas, Inc. | 1982-05-14 | 14 | 0 |
| K812501 | OPRAFLEX | Selomas, Inc. | 1981-10-02 | 32 | 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