# K133057: Vibralung Acoustical Percussor

- Pathway: 510(k) (Traditional)
- Applicant: Westmed, Inc.
- Decided: May 23, 2014 after 238 days
- Product code: SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices)
- 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: 7 generations back to K884098 (1988). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063645: Frequencer, Model 1001, Dymedso, Inc. (2007) Summary page 1.
- K100749: Frequencer Model V2X, Dymedso, Inc. (2010) Summary page 3.
- K103176: Frequencer, Dymedso, Inc. (2011) Summary page 1.
- K991561: Roadrunner, Pep Therapy Device, Dhd Healthcare Corp. (1999) Summary page 1.
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 1.
- K091557: Lung Flute Therapeutic, Medical Acoustics (2010) Summary page 1.

## Indications for use
The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery. Patient Population - Cystic Fibrosis, COPD, asthma and lung diseases with secretory problems, patients with neuromuscular disease affecting the ability to effectively cough. Anyone who is able to read and / or follow verbal instructions Environment of Use — Hospital and Home

Source page: https://510kreport.com/device/K133057
Methodology: https://510kreport.com/methodology