De Novo · Granted
GrantedCurve Positive Airway Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresca Medical · QBY Positive Airway Pressure System
Granted on Jun 5, 2018 as a new device type through De Novo after a 173-day review. 1 later device descends from it.
- Decided
- Jun 5, 2018
- Review
- 173 days
- Class
- Class II
- Product code
- QBY
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN170089 Curve Positive Airway Pressure SystemFresca Medical · 2018
- Descendant · cites it directly · 0 of its ownK200698 Somnera SystemFresca Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200698Somnera SystemFresca Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170089 | Curve Positive Airway Pressure System | Fresca Medical | 2018 | — |
| +1 | K200698 | Somnera System | Fresca Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QBY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBY device
- #1 K200698 Somnera Systemscore -0.4 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200698 | Somnera System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200698 (Fresca Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QBY devicesQBY Positive Airway Pressure System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QBY
Too few QBY 510(k)s in any year since 2007 to give a median.
Recalls per year · QBY
No recall names QBY since 2007.
Adverse event reports per year · QBY
1in 2025
MAUDE reports naming product code QBY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170089 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN170089: Curve Positive Airway Pressure System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN170089
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026