# K162041: Airworks Nebulizer pe1200m

- Pathway: 510(k) (Traditional)
- Applicant: Convexity Scientific, LLC
- Decided: May 2, 2017 after 281 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923024 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032849: Aeroneb GO Nebulizer, Model AG-AG2000, Aerogen, Inc. (2003) Summary page 4.

## Indications for use
The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.

Source page: https://510kreport.com/device/K162041
Methodology: https://510kreport.com/methodology