510(k) · Cleared
ClearedZQuiet
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 Jun 12, 2018 as substantially equivalent to K093407 (Sleeping Well, LLC, 2010) after a 147-day review. Its family tree reaches back 6 generations to 1989. 6 later devices descend from it.
- Decided
- Jun 12, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K882303 (1989). 12 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 4 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 3 generations backK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- 2 generations backK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- 1 generation backK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- This deviceK180124 ZQuietSleeping Well, LLC · 2018
- Descendant · cites it directly · 3 of its ownK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
- Descendant · 2 generations on · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · cites it directly · 1 of its ownK201719 Vital SleepThe Snore Reliever Company, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253868 QuietLab ProQuietLab, LLC · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191618SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019 · cites it directly3descendants
- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · 2 generations on1descendant
- K201719Vital SleepThe Snore Reliever Company, LLC · 2021 · cites it directly1descendant
- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · 3 generations on0descendants
- K253868QuietLab ProQuietLab, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −5 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −4 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −3 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| −2 | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| −1 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| 0 (this device) | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| +1 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
| +2 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +1 | K201719 | Vital Sleep | The Snore Reliever Company, LLC | 2021 | — |
| +3 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
| +1 | K253868 | QuietLab Pro | QuietLab, LLC | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K093407 | Zquiet MouthpieceSummary page 4…n name Device, Anti-Snoring, 21 CFR 872.5570, LRK, Class II 7 Legally Marketed Device To Which The Device Is Substantially Equivalent • Primary Predicate - ZQuiet , K093407 1 • Reference Predicate - ZQuiet , K090503 • Reference Pr… | 2010 |
| † | K090503 | Zquiet Mouthpiece | 2009 |
| † | K170825 | SnoreRx | 2017 |
What descends from it? (6)
4 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 29 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K191618 (Michael D Williams Dds PA, 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K093407.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180124: ZQuiet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180124
Report an extraction error
Are you the manufacturer?
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