# K233441: The Vest APX System (PVAPX1)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corportation
- Decided: Mar 22, 2024 after 156 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: 6 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)
- K142482: The Vest Airway Clearance System, Hill-Rom Services Private Limited (2015) Summary page 5.

## Indications for use
The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, The Vest APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation. The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

Source page: https://510kreport.com/device/K233441
Methodology: https://510kreport.com/methodology