510(k) · Cleared
ClearedSomnoguard SP Soft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomed Dr. Toussaint GmbH · LRK Device, Anti-Snoring
Cleared on Sep 28, 2012 as substantially equivalent to K061688 (Tomed Dr. Toussaint GmbH, 2006) and 1 other predicate after a 105-day review. Its family tree reaches back 4 generations to 1989. 2 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K882303 (1989). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 1 generation backK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- This deviceK121761 Somnoguard SP SoftTomed Dr. Toussaint GmbH · 2012
- Descendant · cites it directly · 0 of its ownK253868 QuietLab ProQuietLab, LLC · 2025
- Descendant · cites it directly · 0 of its ownK150566 OnirisSas Oniris · 2016
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 |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −1 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| 0 (this device) | K121761 | Somnoguard SP Soft | Tomed Dr. Toussaint GmbH | 2012 | — |
| +1 | K253868 | QuietLab Pro | QuietLab, LLC | 2025 | — |
| +1 | K150566 | Oniris | Sas Oniris | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K061688 | Anti-Snoring / Sleep Apnea DeviceSummary page 1…vice Classification Status: Class HI per regulations §872.5570 Product Codes: LRK, Predicate Dev ices: * SomnoGuard® AP (K061688), Tomed Dr. Toussaint GmbH 0 SilentNite® (K912424)… | 2006 |
| * | K972424 | Silentnite Our reading of the summary gave K912424, FDA’s number for Vital-Port Vascular Access System 7010 and 7110 (Med Institute, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SilentNite®”. | 1997 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K253868 (QuietLab, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K061688.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SomnoGuard® SP Soft is a mandibular advancement device and is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSAS) in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121761: Somnoguard SP Soft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121761
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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