# K972042: Pari Pep Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Pari Holding Co.
- Decided: Aug 5, 1997 after 64 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K090829: Pari Pep S (2009), 0 descendants of its own
- K991788: Salter Labs Pep Device (1999), 0 descendants of its own

## Indications for use
The PARI PEP Device is an Expiratory Resistance Exerciser and was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home, doctor's office, hospitals and clinics. The PARI PEP was designed to work with the PARI Nebulizers.

Source page: https://510kreport.com/device/K972042
Methodology: https://510kreport.com/methodology