# K053248: Smartvest Airway Clearance System, Model TL

- Pathway: 510(k) (Traditional)
- Applicant: Electromed, Inc.
- Decided: Dec 1, 2005 after 10 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: 3 generations back to K884098 (1988). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040367: Medpulse Respiratory Vest System, Model 2000EZ, Electromed, Inc. (2004) Summary page 1.

## Most influential descendants
- K122480: International Biophysics Corporation Afflovest (2013), 2 descendants of its own
- K132794: Smartvest Airway Clearance System (2013), 1 descendant of its own
- K252849: AffloVest® Mobile Airway Clearance Therapy (2026), 0 descendants of its own
- K250860: BreatheBand® (Model 1000) (2025), 0 descendants of its own
- K222496: Electromed SmartVest Airway Clearance System (2022), 0 descendants of its own

## Indications for use
The Electromed SmartVest® Airway Clearance System, Model TL 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/K053248
Methodology: https://510kreport.com/methodology