# K132794: Smartvest Airway Clearance System

- Pathway: 510(k) (Special)
- Applicant: Electromed, Inc.
- Decided: Dec 19, 2013 after 104 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K222496: Electromed SmartVest Airway Clearance System (2022), 0 descendants of its own

## Indications for use
The SmartVest Airway Clearance System, Model SQL 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/K132794
Methodology: https://510kreport.com/methodology