510(k) · Cleared
ClearedSnore Bandit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Snorebandit, LLC · LRK Device, Anti-Snoring
Cleared on Jul 1, 2021 as substantially equivalent to K191618 (Michael D Williams Dds PA, 2019) and 2 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Jul 1, 2021
- Review
- 94 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K882303 (1989). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 5 generations backK061688 Anti-Snoring / Sleep Apnea DeviceTomed Dr. Toussaint GmbH · 2006
- 4 generations backK090503 Zquiet MouthpieceSleeping Well, LLC · 2009
- 3 generations backK093407 Zquiet MouthpieceSleeping Well, LLC · 2010
- 2 generations backK180124 ZQuietSleeping Well, LLC · 2018
- 1 generation backK191618 SleepTight Mouthpiece STZMichael D Williams Dds PA · 2019
- This deviceK210910 Snore BanditSnorebandit, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −5 | K061688 | Anti-Snoring / Sleep Apnea Device | Tomed Dr. Toussaint GmbH | 2006 | — |
| −4 | K090503 | Zquiet Mouthpiece | Sleeping Well, LLC | 2009 | — |
| −3 | K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | 2010 | — |
| −2 | K180124 | ZQuiet | Sleeping Well, LLC | 2018 | — |
| −1 | K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | 2019 | — |
| 0 (this device) | 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 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K191618 | SleepTight Mouthpiece STZSummary page 4…vice, anti-snoring (Class II, 21 CFR 872.5570, Product Code LRK) Primary Predicate Device: Sleep Tight Mouthpiece STZ (K191618)-OTC Reference Reference Predicate Devices: Pure Sleep (K190058) – Over the Counter Reference… | 2019 |
| * | K190058 | PureSleep (OTC use)Summary page 4…R 872.5570, Product Code LRK) Primary Predicate Device: Sleep Tight Mouthpiece STZ (K191618)-OTC Reference Reference Predicate Devices: Pure Sleep (K190058) – Over the Counter Reference ZQuiet (K180124) – Over the Counter Reference Description… | 2019 |
| * | K180124 | ZQuietSummary page 4…thpiece STZ (K191618)-OTC Reference Reference Predicate Devices: Pure Sleep (K190058) – Over the Counter Reference ZQuiet (K180124) – Over the Counter Reference Description of the Device The Snore Bandit Anti-Snoring Appliance advances and holds the lower j… | 2018 |
| † | K201484 | Somnos Anti-Snoring Mouth Guard | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- None of the 25 ancestors has a recall.
- 1 other device also cites its predicate K191618.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210910 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210910: Snore Bandit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210910
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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