# K090829: Pari Pep S

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: Jul 21, 2009 after 117 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- 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 K954492 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972042: Pari Pep Therapy System, Pari Holding Co. (1997) Summary page 1.
- K983467: Therapep, Dhd Healthcare Corp. (1999) Summary page 1.

## Indications for use
The PARI PEP S is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients exercise their lungs properly and improve secretion clearance. The PARI PEP S may be used by itself or in conjunction with aerosol drug therapy. The PARI PEP S is intended for adult and pediatric patients, for use in home, hospital, and sub-acute institutions.

Source page: https://510kreport.com/device/K090829
Methodology: https://510kreport.com/methodology