# K192000: D R Burton OxyPAP

- Pathway: 510(k) (Traditional)
- Applicant: D R Burton Healthcare, LLC
- Decided: Feb 19, 2020 after 208 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy. Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time. The environment of use is for hospital and clinical setting.

Source page: https://510kreport.com/device/K192000
Methodology: https://510kreport.com/methodology