# K183108: Combined Aerobika OPEP and VersaPAP device

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical International
- Decided: Aug 16, 2019 after 281 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: 3 generations back to K002768 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150173: Aerobika OPEP Devive with Manometer, Trudell Medical International (2015) Summary page 4.
- K173918: VersaPAP Positive Airway Pressure (PAP) Device, Trudell Medical International (2018) Summary page 4.

## Indications for use
The Combined VersaPAP™ and Aerobika® OPEP device is intended for use as a Positive Airway Pressure (PAP) device and a Positive Expiratory Pressure (PEP) device. The combined device has the ability to provide supplemental oxygen when used with compressed oxygen. The combined device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy and capable of generating exhalation flow of 10 lpm for 3 – 4 seconds. The combined device is a single patient, multiple use device intended to be used in a hospital environment under the supervision of a healthcare professional.

Source page: https://510kreport.com/device/K183108
Methodology: https://510kreport.com/methodology