# K123400: Aerobika  Positive Expiratory Pressure Device

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: May 16, 2013 after 192 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 K002768 (2000). 1 ancestor in all.
2 later devices descend 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)
- K002768: Acapella, Dhd Healthcare Corp. (2000) Summary page 1.

## Most influential descendants
- K150173: Aerobika OPEP Devive with Manometer (2015), 1 descendant of its own
- K183108: Combined Aerobika OPEP and VersaPAP device (2019), 0 descendants of its own

## Indications for use
The Aeroblka* Oscillating Positive Expiratory Pressure device is Intended for use as a Positive Expiratory Pressure (PEP) device. The Aeroblka* 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 1pm for 3 -4 seconds.

Source page: https://510kreport.com/device/K123400
Methodology: https://510kreport.com/methodology