510(k) Report

510(k) · Cleared

Cleared

Snorenti

K032410510(k) TraditionalCleared Feb 28, 2005574-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

James P Boyd · LQZ Device, Jaw Repositioning

Cleared on Feb 28, 2005 after a 574-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.

Decided
Feb 28, 2005
Review
574 days
Class
Class II
Product code
LQZ
Recalls
None
Predicates
0

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2012: 2 descendants cleared2011: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK032410 SnorentiJames P Boyd · 2005
  2. Descendant · cites it directly · 9 of its ownK053065 Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior…Bryan Keropian Dds · 2006
  3. Descendant · cites it directly · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
  4. Descendant · cites it directly · 8 of its ownK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
  5. Descendant · cites it directly · 7 of its ownK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
  6. Descendant · 2 generations on · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22009: 12011: 12012: 22019: 12021: 12026: 2
2005high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all
  • K053065Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps)Bryan Keropian Dds · 2006 · cites it directly9descendants
  • K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · cites it directly9descendants
  • K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006 · cites it directly8descendants
  • K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009 · cites it directly7descendants
  • K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032410SnorentiJames P Boyd2005—
+1K053065Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with…Bryan Keropian Dds2006—
+1K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds2005—
+1K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds2006—
+1K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds2009—
+2K111680DR. Greensburg's HybridAlways More Marketing, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200910
201110
201220
201910
202110
202620
FIG. 1 — Lineage of K032410, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQZ? 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 LQZ device

  1. #1 K233754 AIO Breathescore 12.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053065Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps)Bryan Keropian Dds20069
K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds20059
K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds20068
K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds20097

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?

  • Of its descendants, K053065 (Bryan Keropian Dds, 2006) has gone furthest, with 9 descendants of its own.

How does its category compare?

All LQZ devices

LQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQZ

1in 2024

2009: 22011: 12012: 22013: 12017: 12020: 22021: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQZ

Too few LQZ 510(k)s in any year since 2007 to give a median.

Recalls per year · LQZ

No recall names LQZ since 2007.

Adverse event reports per year · LQZ

2in 2021

2009: 12010: 12012: 22014: 22016: 42017: 12021: 2
2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LQZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—01
20100—01
20111—00
20122—02
20131—00
20140—02
20150—00
20160—04
20171—01
20180—00
20190—00
20202—00
20211—02
20220—00
20231—00
20241—00
20250—00
20260—0—

What is it indicated for?

1. Quiet Night - This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.

2. Quiet Night MA - This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. This appliance is intended for use when the Quiet Night is ineffective.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in LQZ

The LQZ category page

  • K233754AIO BreatheAiomega, LLC · 2024
  • K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC · 2023
  • K203712The SlideBiotex, Inc. · 2021
  • K191320Slow Wave DS8Slow Wave, Inc. · 2020
  • K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020

https://510kreport.com/device/K032410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032410: Snorenti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032410

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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