# K122480: International Biophysics Corporation Afflovest

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corporation
- Decided: Mar 27, 2013 after 225 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: 4 generations back to K884098 (1988). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965192: Thairapy Vest System, American Biosystems, Inc. (1997) Summary page 1.
- K053248: Smartvest Airway Clearance System, Model TL, Electromed, Inc. (2005) Summary page 2.

## Most influential descendants
- K252849: AffloVest® Mobile Airway Clearance Therapy (2026), 0 descendants of its own
- K250860: BreatheBand® (Model 1000) (2025), 0 descendants of its own

## Indications for use
The International Biophysics Corporation AffioVest 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.

Source page: https://510kreport.com/device/K122480
Methodology: https://510kreport.com/methodology