510(k) · Cleared
ClearedSomnoDent ALPHA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomed, Inc. · LRK Device, Anti-Snoring
Cleared on Sep 20, 2016 as substantially equivalent to K140278 (Somnomed, Inc., 2014) and 1 other predicate after a 34-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Sep 20, 2016
- Review
- 34 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K882303 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 5 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 4 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 3 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 2 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 1 generation backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- This deviceK162306 SomnoDent ALPHASomnomed, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −5 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −4 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −3 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −2 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −1 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| 0 (this device) | K162306 | SomnoDent ALPHA | Somnomed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, FlexSummary page 4…Number PRIMARY = SomnoDent® SomnoMed Inc. K140278 SomnoDent Fusion ALPHA® REFERNCE = TOA/myTAP… | 2014 |
| * | K972061 | TOASummary page 4…K140278 SomnoDent Fusion ALPHA® REFERNCE = TOA/myTAP Airway Management K972061 The SomnoDent ALPHA is substantially equivalent to the predicates listed above, currently in commercial distribution.… | 1997 |
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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K140278.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162306: SomnoDent ALPHA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162306
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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