# K012368: Aeropep

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: Feb 12, 2002 after 201 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The “AERO PEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device can be used as a PEP device alone or in conjunction with the delivery of aerosolized medication from a pressurized metered dose inhaler (pMDI) as prescribed by a physician or health care provider.

Source page: https://510kreport.com/device/K012368
Methodology: https://510kreport.com/methodology