# K050183: Silfab Super 2 Max Compressor, N28 Series

- Pathway: 510(k) (Traditional)
- Applicant: Silvestrin Fabris S.R.L.
- Decided: Aug 16, 2005 after 201 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 SILFAB model Super 2 Max N28 Compressor ! Nebulizer is an AC-powered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc

Source page: https://510kreport.com/device/K050183
Methodology: https://510kreport.com/methodology