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 Jan 18, 2023 after a 64-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Jan 18, 2023
- Review
- 64 days
- Class
- Class II
- Product code
- QNO
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK223446 eXciteOSA without remote control (3000); eXciteOSA with remote…Signifier Medical Technologies, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240328 eXciteOSA without remote control (3000); eXciteOSA with remote…Signifier Medical Technologies, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240328eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Signifier Medical Technologies, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2023 | — |
| +1 | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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.
Top candidate predicates for a new QNO device
- #1 K240328 eXciteOSA without remote control (3000)…score 7.3 · 1 generation · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | DEN200018 | FDA’s DEN200018 is eXciteOSA with remote and eXciteOSA without remote Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2021 |
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 |
|---|---|---|---|
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | 2024 | 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, K240328 (Signifier Medical Technologies, Ltd., 2024) has gone furthest, with 0 descendants of its own.
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. 2023, 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/K223446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223446: 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/K223446
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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