# DEN170089: Curve Positive Airway Pressure System

- Pathway: De Novo (Direct)
- Applicant: Fresca Medical
- Decided: Jun 5, 2018 after 173 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200698: Somnera System (2020), 0 descendants of its own

## Indications for use
The CURVE™ Positive Airway Pressure 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 also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).

Source page: https://510kreport.com/device/DEN170089
Methodology: https://510kreport.com/methodology