# K150044: O-PEP

- Pathway: 510(k) (Traditional)
- Applicant: Pari Respiratory Equipment, Inc.
- Decided: May 27, 2016 after 501 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 K940986 (1994). 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)
- K972859: Flutter D, Bradstreet Clinical Research Assoc., Inc. (1998) Summary page 4.
- K946083: Flutter (R), Bradstreet Clinical Research Assoc., Inc. (1995) Summary page 4.

## Indications for use
The PARI O-PEP is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients improve secretion clearance. The PARI O-PEP is intended for adult and pediatric patients ages 5 and older, for use in home, hospital, and sub-acute institutions.

Source page: https://510kreport.com/device/K150044
Methodology: https://510kreport.com/methodology