Company · IE
Aerogen, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2025 | K251615 | Aerogen Pro-X1 Controller System Aerogen, Ltd., IE | SFP |
| May 10, 2024 | K232507 | Aerogen®Solo Nebulizer System Aerogen, Ltd., IE | CAF |
| Jul 10, 2015 | K143719 | Aeroneb USB Contoller System Aerogen Limited, IE | CAF |
| Oct 17, 2014 | K133360 | AERONEB SOLO; AERONEB SOLO ADAPTER Aerogen, Ltd., IE | CAF |
| Apr 26, 2012 | K120939 | AERONEB PRO Aerogen, Ltd., IE | CAF |
| May 13, 2011 | K103635 | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S Aerogen, Ltd., IE | CAF |
| Nov 21, 2003 | K032849 | AERONEB GO NEBULIZER, MODEL AG-AG2000 Aerogen, Inc. | CAF |
| May 15, 2002 | K021175 | AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 Aerogen, Inc. | CAF |
| Oct 13, 2000 | K003022 | AERONEB PORTABLE NEBULIZER Aerogen, Inc. | CAF |
| Aug 25, 2000 | K992831 | AERONEB II, MODEL APN 200 Aerogen, Inc. | CAF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |
| Oct 23, 2014 | Aerogen Ltd. The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off vent Terminated |
CAF | K021175 |