510(k) · Cleared
ClearedSomnodent Fusion, Classic; Somnodent Fusion, Flex
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 Jun 20, 2014 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 3 other predicates after a 137-day review. Its family tree reaches back 7 generations to 1989. 14 later devices descend from it.
- Decided
- Jun 20, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K882303 (1989). 8 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 4 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 3 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 2 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 1 generation backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- This deviceK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- Descendant · 4 generations on · 1 of its ownK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Somnomed, Inc. · 2015 · cites it directly12descendants
- K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016 · 2 generations on5descendants
- K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc. · 2020 · 3 generations on2descendants
- K170692Respire Pink Series with DentiTracRespire Medical Holding · 2017 · 2 generations on2descendants
- K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −4 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −3 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −2 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −1 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| 0 (this device) | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| +1 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| +2 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016 | — |
| +3 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… | Prosomnus Sleep Technologies, Inc. | 2020 | — |
| +2 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| +4 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 1…ring Regulation Number: 21 CFR 872.5570 Product Code: LRK Class: 11 Panel: Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K1 21 340, SomnoDent G2… | 2005 |
| * | K073004 | Somnomed BflexSummary page 1…t Code: LRK Class: 11 Panel: Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K1 21 340, SomnoDent G2 K130558, Somnooent Herbst Descript… | 2008 |
| * | K121340 | Somnodent G2Summary page 1…11 Panel: Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K1 21 340, SomnoDent G2 K130558, Somnooent Herbst Description of the device: The SomnoDent Fusion is an intraor… | 2012 |
| * | K130558 | Somnodent Herbst; Classic, FlexSummary page 1…ices: K050592, SomnoDent Classic K073004, SomnoDent Flex K1 21 340, SomnoDent G2 K130558, Somnooent Herbst Description of the device: The SomnoDent Fusion is an intraoral device intended for the treatment of nighttime… | 2013 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K150369 (Somnomed, Inc., 2015) has gone furthest, with 12 descendants of its own.
- 16 other devices also cite its predicate K050592.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Fusion is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140278: Somnodent Fusion, Classic; Somnodent Fusion, Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140278
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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