# Aerogen, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 10 (2000–2025): 10 510(k) clearances
- Names in FDA's records: Aerogen, Ltd. (5); Aerogen, Inc. (4); Aerogen Limited (1)
- Product codes: CAF (9), SFP (1)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 10 (5 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fluid Propulsion Technologies, Inc.: 3 (https://510kreport.com/company/fluid-propulsion-technologies)
- Pacesetter, Inc.: 1 (https://510kreport.com/company/pacesetter)
- Aerogen (Ireland), Ltd.: 1 (https://510kreport.com/company/aerogen-ireland)
- Pari Holding Co.: 1 (https://510kreport.com/company/pari-holding)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)

## Firms that cite its devices most
- Pari Innovative Manufacturers, Inc.: 2 (https://510kreport.com/company/pari-innovative-manufacturers)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Vapotherm, Inc.: 1 (https://510kreport.com/company/vapotherm)
- Convexity Scientific, LLC: 1 (https://510kreport.com/company/convexity-scientific)

## Its most-cited devices
- K133360: Aeroneb Solo; Aeroneb Solo Adapter (2014), cited by 4
- K003022: Aeroneb Portable Nebulizer (2000), cited by 3
- K120939: Aeroneb Pro (2012), cited by 1
- K032849: Aeroneb GO Nebulizer, Model AG-AG2000 (2003), cited by 1
- K992831: Aeroneb II, Model Apn 200 (2000), cited by 1

## Recent decisions
- K251615: Aerogen Pro-X1 Controller System (Sep 2, 2025)
- K232507: Aerogen®Solo Nebulizer System (May 10, 2024)
- K143719: Aeroneb  USB Contoller System (Jul 10, 2015)
- K133360: Aeroneb Solo; Aeroneb Solo Adapter (Oct 17, 2014)
- K120939: Aeroneb Pro (Apr 26, 2012)
- K103635: Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S (May 13, 2011)
- K032849: Aeroneb GO Nebulizer, Model AG-AG2000 (Nov 21, 2003)
- K021175: Aeroneb Professional Nebulizer System, Model#AG-AP6000 (May 15, 2002)

Source page: https://510kreport.com/company/aerogen