510(k) · Cleared
ClearedQuietLab Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QuietLab, LLC · LRK Device, Anti-Snoring
Cleared on Dec 5, 2025 as substantially equivalent to K180124 (Sleeping Well, LLC, 2018) and 3 other predicates after a 2-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Dec 5, 2025
- Review
- 2 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K882303 (1989). 19 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 backK201719 Vital SleepThe Snore Reliever Company, LLC · 2021
- This deviceK253868 QuietLab ProQuietLab, LLC · 2025
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 | K201719 | Vital Sleep | The Snore Reliever Company, LLC | 2021 | — |
| 0 (this device) | 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 |
| 1997 | 1 | 0 |
| 2004 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K180124 | ZQuietSummary page 5…872.5570 Product Code(s) LRK | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180124 ZQuiet OTC LRK K213088 ZQuiet Advance LRK K201719 Vital Sleep LRK K121761 SomnoGuard SP Soft LRK Device Description Summary 21 CF… | 2018 |
| * | K213088 | ZQuiet AdvanceSummary page 5…s) LRK | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180124 ZQuiet OTC LRK K213088 ZQuiet Advance LRK K201719 Vital Sleep LRK K121761 SomnoGuard SP Soft LRK Device Description Summary 21 CFR 807.92(a)(4) The Qui… | 2022 |
| * | K201719 | Vital SleepSummary page 5…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180124 ZQuiet OTC LRK K213088 ZQuiet Advance LRK K201719 Vital Sleep LRK K121761 SomnoGuard SP Soft LRK Device Description Summary 21 CFR 807.92(a)(4) The QuietLab Pro Anti-Snoring Mout… | 2021 |
| * | K121761 | Somnoguard SP SoftSummary page 5…807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180124 ZQuiet OTC LRK K213088 ZQuiet Advance LRK K201719 Vital Sleep LRK K121761 SomnoGuard SP Soft LRK Device Description Summary 21 CFR 807.92(a)(4) The QuietLab Pro Anti-Snoring Mouthpiece is a reusable, ov… | 2012 |
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 36 years and passes through 7 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 3 other devices also cite its predicate K180124.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Intended as an aid in the reduction of snoring for adults at least 18 years old.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253868: QuietLab Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253868
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