# K173918: VersaPAP Positive Airway Pressure (PAP) Device

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical International
- Decided: Aug 17, 2018 after 238 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 K944900 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device, Dhd Healthcare Corp. (1999) Summary page 4.

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

## Indications for use
VersaPAP* is indicated for the treatment and prevention of atelectasis. VersaPAP* also has the ability to provide supplemental oxygen when used with compressed oxygen. The VersaPAP* device is for patients (ages 5 years and above) who are capable of following directions for Positive Airway Pressure Therapy in a hospital environment. The VersaPAP* device is a single patient, multiple use device intended to be used under the supervision of a healthcare professional.

Source page: https://510kreport.com/device/K173918
Methodology: https://510kreport.com/methodology