# K971933: Port-Neb

- Pathway: 510(k) (Traditional)
- Applicant: Medic-Aid, Ltd.
- Decided: Aug 1, 1997 after 66 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K085520: DeVilbiss Pulmo-Aide. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer in the home, nursing home or hospital environments.

Source page: https://510kreport.com/device/K971933
Methodology: https://510kreport.com/methodology