# K252849: AffloVest® Mobile Airway Clearance Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Tactile Medical
- Decided: Apr 30, 2026 after 234 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 5.

## Indications for use
The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The AffloVest may be used for the pediatric population (≥6 months of age) to geriatric population.

Source page: https://510kreport.com/device/K252849
Methodology: https://510kreport.com/methodology