# K191270: Proneb Max

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: Jan 23, 2020 after 255 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
Longest line of descent: 3 generations back to K963924 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092918: Pari Vios, Pari Respiratory Equipment, Inc. (2010) Summary page 4.

## Indications for use
The PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 2 years and older, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Source page: https://510kreport.com/device/K191270
Methodology: https://510kreport.com/methodology