Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aerogen, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
350 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | Aerogen, Ltd. | 2025-09-02 | 98 | 0 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 | 266 | 0 |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | Aerogen, Ltd. | 2014-10-17 | 350 | 0 |
| K120939 | AERONEB PRO | Aerogen, Ltd. | 2012-04-26 | 28 | 0 |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + | Aerogen, Ltd. | 2011-05-13 | 151 | 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