# K040367: Medpulse Respiratory Vest System, Model 2000EZ

- Pathway: 510(k) (Special)
- Applicant: Electromed, Inc.
- Decided: Apr 7, 2004 after 54 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: 2 generations back to K884098 (1988). 2 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K982889: Medpulse Respiratory Vest System, Model 1000, Electromed, Inc. (1999) Summary page 1.

## Most influential descendants
- K053248: Smartvest Airway Clearance System, Model TL (2005), 5 descendants of its own
- 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

## Indications for use
The Electromed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

Source page: https://510kreport.com/device/K040367
Methodology: https://510kreport.com/methodology