Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aerogen, 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) |
|---|---|---|---|---|---|
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 | Aerogen, Inc. | 2003-11-21 | 70 | 1 |
| K021175 | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 | Aerogen, Inc. | 2002-05-15 | 33 | 4 |
| K003022 | AERONEB PORTABLE NEBULIZER | Aerogen, Inc. | 2000-10-13 | 15 | 0 |
| K992831 | AERONEB II, MODEL APN 200 | Aerogen, Inc. | 2000-08-25 | 368 | 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