# K150173: Aerobika OPEP Devive with Manometer

- Pathway: 510(k) (Special)
- Applicant: Trudell Medical International
- Decided: Oct 15, 2015 after 262 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: 2 generations back to K002768 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123400: Aerobika  Positive Expiratory Pressure Device, Trudell Medical Intl. (2013) Summary page 4.

## Most influential descendants
- K183108: Combined Aerobika OPEP and VersaPAP device (2019), 0 descendants of its own

## Indications for use
The Aerobika* Oscillating Positive Expiratory Pressure device is intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 Ipm for 3 - 4 seconds.

Source page: https://510kreport.com/device/K150173
Methodology: https://510kreport.com/methodology