# K250860: BreatheBand® (Model 1000)

- Pathway: 510(k) (Traditional)
- Applicant: Exemplar Medical, LLC
- Decided: Oct 2, 2025 after 195 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K884098 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122480: International Biophysics Corporation Afflovest, International Biophysics Corporation (2013) Summary page 6.

## Indications for use
The BreatheBand® device is intended to deliver high-frequency chest wall oscillation (HFCWO) therapy to promote airway clearance and aid in general bronchial drainage when external chest manipulation or manipulation of the thorax is the physician's treatment of choice to enhance mucus transport. It is indicated for adult patients (22 years of age and older) experiencing difficulty with secretion clearance. The BreatheBand® device is intended for use in the home-care environment. The BreatheBand® device is non-invasive, reusable, and intended for single-patient use.

Source page: https://510kreport.com/device/K250860
Methodology: https://510kreport.com/methodology