Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novabay Pharmaceuticals — 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) |
|---|---|---|---|---|---|
| K113820 | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER | Novabay Pharmaceuticals | 2012-08-08 | 225 | 0 |
| K081009 | NEUTROPHASE | Novabay Pharmaceuticals | 2008-05-20 | 42 | 0 |
| K071056 | NEUTROPHASE WOUND CLEANSER | Novabay Pharmaceuticals | 2007-09-28 | 165 | 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