# K092560: Pari Sinus

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: May 6, 2010 after 259 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: 2 generations back to K963924 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061381: LC Star with Nasal Adapter, Pari Innovative Manufacturers, Inc. (2006) Summary page 1.
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 1.
- K002862: Proneb Ultra Model Number 85B0100, Pari Holding Co. (2001) Summary page 1.
- K060399: LC Sprint Nebulizer, Pari Innovative Manufacturers, Inc. (2006) Summary page 1.

## Indications for use
The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.

Source page: https://510kreport.com/device/K092560
Methodology: https://510kreport.com/methodology