# K203378: Pulsehaler

- Pathway: 510(k) (Traditional)
- Applicant: Respinova, Ltd.
- Decided: Mar 31, 2021 after 134 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: 4 generations back to K954492 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140772: Aerosure Medic, Actegy, Ltd. (2014) Summary page 4.

## Indications for use
Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device. • The use of Pulsehaler™ improves clearance of secretions • The use of Pulsehaler™ may reduce the need for postural drainage • Pulsehaler™ facilitates opening of airways in patients • Pulsehaler™ may be used to prevent or reverse atelectasis • Pulsehaler™ may also be useful in the removal of mucus from the lungs Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.

Source page: https://510kreport.com/device/K203378
Methodology: https://510kreport.com/methodology