# K072494: AG-Classic

- Pathway: 510(k) (Abbreviated)
- Applicant: Medel S.P.A.
- Decided: Feb 12, 2008 after 160 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times. The use of the Medel AG-CLASSIC is for the production of medical aerosols with approved medications and requires the order of a physician for medical use. The AG-CLASSIC is not intended as a life sustaining or life-supporting device.

Source page: https://510kreport.com/device/K072494
Methodology: https://510kreport.com/methodology