# K242063: LibAirty Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Synchrony Medical, Ltd.
- Decided: Dec 19, 2024 after 157 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 LibAirty Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.

Source page: https://510kreport.com/device/K242063
Methodology: https://510kreport.com/methodology