# K070990: Apex Medical Mobineb, 9R-027 Series

- Pathway: 510(k) (Special)
- Applicant: Apex Medical Corp.
- Decided: May 18, 2007 after 39 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 9R-027XXX Series, MobiNeb are designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine.

Source page: https://510kreport.com/device/K070990
Methodology: https://510kreport.com/methodology