510(k) · Cleared
ClearedZquiet Mouthpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleeping Well, LLC · LRK Device, Anti-Snoring
Cleared on Mar 10, 2009 as substantially equivalent to K061688 (Tomed Dr. Toussaint GmbH, 2006) after a 13-day review. Its family tree reaches back 4 generations to 1989. 10 later devices descend from it.
- Decided
- Mar 10, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882303 (1989). 10 ancestors in all. 10 later devices descend from it, 3 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 deviceK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- Descendant · cites it directly · 8 of its ownK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- Descendant · 2 generations on · 6 of its ownK180124 ZQuietSleeping Well, LLC · 2018
- Descendant · 3 generations on · 3 of its ownK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
- Descendant · 4 generations on · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · 3 generations on · 1 of its ownK201719 Vital SleepThe Snore Reliever Company, LLC · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K093407Zquiet MouthpieceSleeping Well, LLC · 2010 · cites it directly8descendants
- K180124ZQuietSleeping Well, LLC · 2018 · 2 generations on6descendants
- K191618SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019 · 3 generations on3descendants
- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · 4 generations on1descendant
- K201719Vital SleepThe Snore Reliever Company, LLC · 2021 · 3 generations on1descendant
View 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) | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| +1 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| +2 | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| +3 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
| +4 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +3 | K201719 | Vital Sleep | The Snore Reliever Company, LLC | 2021 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | K061688 | Anti-Snoring / Sleep Apnea DeviceSummary page 1…valent Device Company Product 510(k)# Tomed Dr. Toussaint GmbH. Anti-Snoring/Sleep Apnea Device K06 1688 DEVICE DESCRIPTION 807.92(a)(4) The ZQuiet 0 Mouthpiece is an Anti-Snoring device cons… | 2006 |
What descends from it? (10)
3 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 20 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K093407 (Sleeping Well, LLC, 2010) has gone furthest, with 8 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. 2009, 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 ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090503 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090503: Zquiet Mouthpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090503
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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