# K021175: Aeroneb Professional Nebulizer System, Model#AG-AP6000

- Pathway: 510(k) (Traditional)
- Applicant: Aerogen, Inc.
- Decided: May 15, 2002 after 33 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960854 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970010: FPT Nebulizer, Fluid Propulsion Technologies, Inc. (1997) Summary page 1.
- K003022: Aeroneb Portable Nebulizer, Aerogen, Inc. (2000) Summary page 1.
- K960854: Siemens Servo Ultra Nebulizer 345, Pacesetter, Inc. (1996) Summary page 1.

## Recalls of this device
- Sep 2, 2014 · Class II · Z-0118-2015: Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received ident
- Sep 2, 2014 · Class II · Z-0119-2015: Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received ident
- Sep 2, 2014 · Class II · Z-0121-2015: Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received ident
- Sep 2, 2014 · Class II · Z-0120-2015: Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received ident

## Indications for use
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 ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Source page: https://510kreport.com/device/K021175
Methodology: https://510kreport.com/methodology