Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aearo Company · 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) |
|---|---|---|---|---|---|
| K072359 | AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9 | Aearo Company | 2007-11-08 | 78 | 0 |
| K070168 | N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C | Aearo Company | 2007-04-18 | 90 | 0 |
| K063013 | PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S | Aearo Company | 2006-12-01 | 60 | 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