# K983308: RC Cornet, Model #44F50

- Pathway: 510(k) (Traditional)
- Applicant: Pari Holding Co.
- Decided: Jun 4, 1999 after 256 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
- K163091: VibraPEP (2017), 0 descendants of its own
- K153441: VibraPEP (2016), 0 descendants of its own

## Indications for use
The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient’s lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.

Source page: https://510kreport.com/device/K983308
Methodology: https://510kreport.com/methodology