510(k) · Cleared
ClearedSomnera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresca Medical, Inc. · QBY Positive Airway Pressure System
Cleared on Jun 29, 2020 as substantially equivalent to DEN170089 (Fresca Medical, 2018) after a 104-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jun 29, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- QBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170089 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170089 Curve Positive Airway Pressure SystemFresca Medical · 2018
- This deviceK200698 Somnera SystemFresca Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170089 | Curve Positive Airway Pressure System | Fresca Medical | 2018 | — |
| 0 (this device) | K200698 | Somnera System | Fresca Medical, Inc. | 2020 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170089 | Curve Positive Airway Pressure SystemSummary page 4…III. PREDICATE DEVICE Predicate Device: FRESCA Medical CURVE™ Positive Airway Pressure System (DEN170089) Reference Device: Respironics, Inc. Dream Station Go Auto CPAP (K131982) IV. DEVICE DESC… | 2018 |
| † | K131982 | Remstar Auto a-Flex HT | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All QBY devicesQBY Positive Airway Pressure System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200698: Somnera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200698
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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