510(k) · Cleared
ClearedAnti-Snoring / Sleep Apnea Device
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 8, 2006 as substantially equivalent to K962516 (Nellcor Puritan Bennett, Inc., 1996) and 6 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1989. 22 later devices descend from it.
- Decided
- Sep 8, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K882303 (1989). 9 ancestors in all. 22 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- This deviceK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- Descendant · cites it directly · 10 of its ownK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- Descendant · 2 generations on · 8 of its ownK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- Descendant · 3 generations on · 6 of its ownK180124 ZQuietSleeping Well, LLC · 2018
- Descendant · cites it directly · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · 4 generations on · 3 of its ownK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K090503Zquiet MouthpieceSleeping Well, LLC · 2009 · cites it directly10descendants
- K093407Zquiet MouthpieceSleeping Well, LLC · 2010 · 2 generations on8descendants
- K180124ZQuietSleeping Well, LLC · 2018 · 3 generations on6descendants
- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · cites it directly6descendants
- K191618SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| 0 (this device) | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| +1 | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| +2 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| +3 | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| +1 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +4 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K962516 | Tap Anti-Snoring DeviceSummary page 2…t, Silencer (Version I. and II.), TheraSnore, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared:… | 1996 |
| * | K033822 | Respironics Custom I Oral ApplianceSummary page 2…er (Version I. and II.), TheraSnore, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared:… | 2004 |
| * | K033823 | Respironics Custom II Oral ApplianceSummary page 2…on I. and II.), TheraSnore, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared:… | 2004 |
| * | K926382 | TherasnoreSummary page 2…d II.), TheraSnore, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared: Ja… | 1993 |
| * | K972061 | TOASummary page 2…TheraSnore, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared: January 24… | 1997 |
| * | K954530 | The SilencerSummary page 2…re, TAP, Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared: January 24, 1997,… | 1995 |
| * | K042161 | Anti-Snoring/Sleep Apnea DeviceSummary page 2…Silencer, MDSA) 2. K Number: K962516, K033822, 033823, 926382, 972061, 954530, 042161 3. Date Cleared: January 24, 1997, February 6, 2004, February 6, 2004, July… | 2004 |
What descends from it? (22)
See all 229 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 17 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K090503 (Sleeping Well, LLC, 2009) has gone furthest, with 10 descendants of its own.
- 12 other devices also cite its predicate K962516.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Series of mandibular advancement devices (SomnoGuard,2.0,AP and AP Pro) is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061688: Anti-Snoring / Sleep Apnea Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061688
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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