510(k) · Cleared
ClearedeXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signifier Medical Technologies, Ltd. · QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Cleared on May 16, 2024 as substantially equivalent to K223446 (Signifier Medical Technologies, Ltd., 2023) after a 101-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 16, 2024
- Review
- 101 days
- Class
- Class II
- Product code
- QNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K223446 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backK223446 eXciteOSA without remote control (3000); eXciteOSA with remote…Signifier Medical Technologies, Ltd. · 2023
- This deviceK240328 eXciteOSA without remote control (3000); eXciteOSA with remote…Signifier Medical Technologies, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2023 | — |
| 0 (this device) | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2024 | — |
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 QNO? 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 |
|---|---|---|---|
| * | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Summary page 5…ber 872.5575 Product Code QNO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223446 eXciteOSA without remote control, eXciteOSA with remote contgg QNO Device Description Summary 21 CFR 807.92(a)(4) eXciteOSA® is… | 2023 |
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 QNO devicesQNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNO
Too few QNO 510(k)s in any year since 2007 to give a median.
Recalls per year · QNO
No recall names QNO since 2007.
Adverse event reports per year · QNO
1in 2025
MAUDE reports naming product code QNO, 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240328: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240328
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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