# K191728: ULTepap Expiratory Positive Airway Pressure (EPAP) Device

- Pathway: 510(k) (Traditional)
- Applicant: Bryggs Medical, LLC
- Decided: Feb 21, 2020 after 239 days
- Product code: OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K953930 (1996). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50), Ventus Medical, Inc. (2010) Summary page 5.
- K180619: Bongo, Innomed Healthscience, Inc. (2018) Summary page 5.

## Indications for use
ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66lbs.

Source page: https://510kreport.com/device/K191728
Methodology: https://510kreport.com/methodology