510(k) · Cleared
ClearedSomnoDent Avant
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 May 8, 2019 as substantially equivalent to K073004 (Somnomed, Inc., 2008) after a 147-day review. Its family tree reaches back 5 generations to 1989. 2 later devices descend from it.
- Decided
- May 8, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K882303 (1989). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 3 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 2 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 1 generation backK073004 Somnomed BflexSomnomed, Inc. · 2008
- This deviceK183443 SomnoDent AvantSomnomed, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK261366 VirtusSomnomed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK233497 Rest Assure SystemSomnomed, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −3 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −2 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −1 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| 0 (this device) | K183443 | SomnoDent Avant | Somnomed, Inc. | 2019 | — |
| +1 | K261366 | Virtus | Somnomed, Inc. | 2026 | — |
| +1 | K233497 | Rest Assure System | Somnomed, Inc. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K073004 | Somnomed BflexSummary page 4…oderate obstructive sleep apnea (OSA) Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea 21 CFR 872.5570 LRK/PLC Il Dental K073004, SomnoDent Flex Narval CC (K113201) MicrO2 OSA Device (K133683) Description of the device: The SomnoDent Avant device is an i… | 2008 |
| † | K113201 | Narval CC | 2011 |
| † | K133683 | MICR02 Osa Device | 2014 |
What descends from it? (2)
2 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 30 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K261366 (Somnomed, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K073004.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Avant 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183443: SomnoDent Avant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183443
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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