# K222496: Electromed SmartVest Airway Clearance System

- Pathway: 510(k) (Special)
- Applicant: Electromed, Inc.
- Decided: Nov 18, 2022 after 92 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132794: Smartvest Airway Clearance System, Electromed, Inc. (2013) Summary page 4.

## Indications for use
The SmartVest® Airway Clearance System, Model Clearway is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician’s treatment of choice to enhance mucus transport.

Source page: https://510kreport.com/device/K222496
Methodology: https://510kreport.com/methodology