# K163091: VibraPEP

- Pathway: 510(k) (Traditional)
- Applicant: Medica Holdings, LLC
- Decided: Feb 21, 2017 after 109 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983308 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983308: RC Cornet, Model #44F50, Pari Holding Co. (1999) Summary page 4.

## Indications for use
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics. Patient – Patients who have been prescribed PEP Therapy Environment – Hospital, clinics, physician offices, home setting

Source page: https://510kreport.com/device/K163091
Methodology: https://510kreport.com/methodology