# K091557: Lung Flute Therapeutic

- Pathway: 510(k) (Traditional)
- Applicant: Medical Acoustics
- Decided: Jan 4, 2010 after 222 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acapella: named in the summary without a submission number

## Most influential descendants
- K133057: Vibralung Acoustical Percussor (2014), 0 descendants of its own

## Indications for use
The Lung Flute' Therapeutic is indicated for Positive Expiratory Pressure (PEP) Therapy.

Source page: https://510kreport.com/device/K091557
Methodology: https://510kreport.com/methodology