510(k) · Cleared
ClearedSleepTight Mouthpiece STZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michael D Williams Dds PA · LRK Device, Anti-Snoring
Cleared on Dec 11, 2019 as substantially equivalent to K170825 (Apnea Sciences Corporation, 2017) and 2 other predicates after a 176-day review. Its family tree reaches back 7 generations to 1989. 3 later devices descend from it.
- Decided
- Dec 11, 2019
- Review
- 176 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K882303 (1989). 23 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 4 generations backK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- 3 generations backK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- 2 generations backK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- 1 generation backK180124 ZQuietSleeping Well, LLC · 2018
- This deviceK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
- Descendant · cites it directly · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · 2 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
- Descendant · cites it directly · 0 of its ownK210910 Snore BanditSnorebandit, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −4 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| −3 | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| −2 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| −1 | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| 0 (this device) | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
| +1 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +2 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
| +1 | K210910 | Snore Bandit | Snorebandit, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K170825 | SnoreRxSummary page 4…sleep apnea REGULATIONS: 21 CFR 872.5570 PRODUCT CODES: LRK- Anti-Snoring Device 8.1 Identification of Predicate Devices(s) Primary Predicate: SnoreRx K170825 manufactured by Apnea Sciences Corporation. This over the counter Primary Predicate Device is the most similar in indications and… | 2017 |
| * | K132506 | Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep EasySummary page 4…poration. This over the counter Primary Predicate Device is the most similar in indications and technology to the STZ • Reference Device #1: SleepTight Mouthpiece STM K132506 manufactured by Michael D. Williams DDS PA. This Rx Reference Device Predicate supports the scientific methodology… | 2014 |
| * | K180124 | ZQuietSummary page 4…factured by Michael D. Williams DDS PA. This Rx Reference Device Predicate supports the scientific methodology of the STZ. • Reference Device #2: ZQuiet K180124 manufactured by Sleeping Well, LLC. This over the counter Reference Device Predicate also supports the scientific m… | 2018 |
What descends from it? (3)
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 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K252531 (Myofunctional Research Co., 2026) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K170825.
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 SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191618: SleepTight Mouthpiece STZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191618
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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