Aerogen, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Aerogen, Ltd.” (first 2000, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 28 |
| 2013 | 0 | — |
| 2014 | 1 | 350 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 266 |
| 2025 | 1 | 98 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aerogen, Ltd. took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 8 | 8 |
| SFP | Ventilator-Compatible Nebulizer | 1 | 1 |
Review panels
- Anesthesiology (9)
Most recent Aerogen, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251615 | Aerogen Pro-X1 Controller System | SFP | 2025-09-02 | 98 |
| K232507 | Aerogen®Solo Nebulizer System | CAF | 2024-05-10 | 266 |
| K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER | CAF | 2014-10-17 | 350 |
| K120939 | AERONEB PRO | CAF | 2012-04-26 | 28 |
| K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S | CAF | 2011-05-13 | 151 |
| K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 | CAF | 2003-11-21 | 70 |
| K021175 | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 | CAF | 2002-05-15 | 33 |
| K003022 | AERONEB PORTABLE NEBULIZER | CAF | 2000-10-13 | 15 |
| K992831 | AERONEB II, MODEL APN 200 | CAF | 2000-08-25 | 368 |
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-09-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Aerogen, Ltd. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aerogen (Ireland), Ltd. (2 510(k)s)
- Aerogen Ireland, Ltd. (1 510(k)s)
- Aerogen Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aerogen, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Aerogen, Ltd.” (first 2000, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aerogen, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aerogen, Ltd. is 98 days.
Which FDA product codes appear under Aerogen, Ltd.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 8); SFP (Ventilator-Compatible Nebulizer, 1).
Next steps
- See all 9 Aerogen, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Aerogen, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.