Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enzysurge , Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200767 | SilverStream Gel | Enzysurge , Ltd. | 2020-10-08 | 197 | 0 |
| K093227 | SILVERSTREAM AND DERMASEPT | Enzysurge , Ltd. | 2009-12-10 | 57 | 0 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 | 52 | 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