# K063103: AG-Edge, Model 91200

- Pathway: 510(k) (Abbreviated)
- Applicant: Medel S.P.A.
- Decided: Jan 8, 2007 after 90 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 intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication. The AG EDGE is indicated only for use with nebulizer provided and viceversa. The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.

Source page: https://510kreport.com/device/K063103
Methodology: https://510kreport.com/methodology