# K142482: The Vest Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Services Private Limited
- Decided: May 7, 2015 after 245 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). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024309: The Vest Airway Clearance System, Model 104, Advanced Respiratory (2003) Summary page 4.

## Most influential descendants
- K163378: Monarch Airway Clearance System (2017), 2 descendants of its own
- K173603: Monarch Airway Clearance System (2018), 1 descendant of its own
- K242063: LibAirty Airway Clearance System (2024), 0 descendants of its own
- K233441: The Vest APX System (PVAPX1) (2024), 0 descendants of its own
- K201490: Electro Flo 6 Airway Clearance System (2021), 0 descendants of its own

## Indications for use
The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician’s choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, 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® Airway Clearance 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.

Source page: https://510kreport.com/device/K142482
Methodology: https://510kreport.com/methodology