# K200698: Somnera System

- Pathway: 510(k) (Traditional)
- Applicant: Fresca Medical, Inc.
- Decided: Jun 29, 2020 after 104 days
- Product code: QBY (Positive Airway Pressure System)
- Device class: 2
- Regulation: 21 CFR 868.5273
- 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 DEN170089 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170089: Curve Positive Airway Pressure System, Fresca Medical (2018) Summary page 4.

## Indications for use
The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interface; and is intended for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).

Source page: https://510kreport.com/device/K200698
Methodology: https://510kreport.com/methodology