# K972824: The Breather Inspiratory/Expiratory Muscle Trainer

- Pathway: 510(k) (Traditional)
- Applicant: Pn Medical
- Decided: Apr 3, 1998 after 247 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.

Source page: https://510kreport.com/device/K972824
Methodology: https://510kreport.com/methodology