510(k) Report

510(k) · Cleared

Cleared

Snoar (TM) Open Airway Appliance

K880956510(k) TraditionalCleared May 11, 198865-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

Kent J. Toone, D.D.S. · LQZ Device, Jaw Repositioning

Cleared on May 11, 1988 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided
May 11, 1988
Review
65 days
Class
Class II
Product code
LQZ
Recalls
None
Predicates
0

36 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2012: 4 descendants cleared2014: 2 descendants cleared2011: 2 descendants cleared2002: 1 descendant cleared2024: 3 descendants cleared1998: 1 descendant cleared2013: 1 descendant cleared2006: 2 descendants cleared2005: 1 descendant cleared2019: 2 descendants cleared2026: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2025: 3 descendants cleared2009: 1 descendant cleared2021: 3 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK880956 Snoar (TM) Open Airway ApplianceKent J. Toone, D.D.S. · 1988
  2. Descendant · cites it directly · 35 of its ownK971794 Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc. · 1997
  3. Descendant · 2 generations on · 15 of its ownK113201 Narval CCResmed Sas · 2011
  4. Descendant · 2 generations on · 11 of its ownK013808 SleepbiteDental Imagineers, LLC · 2002
  5. Descendant · 3 generations on · 9 of its ownK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
  6. Descendant · 3 generations on · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12002: 12005: 12006: 22009: 12011: 22012: 42013: 12014: 22015: 12016: 12017: 12018: 12019: 22020: 12021: 32022: 12023: 12024: 32025: 32026: 2
1997high 4 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 36 · See all
  • K971794Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc. · 1997 · cites it directly35descendants
  • K113201Narval CCResmed Sas · 2011 · 2 generations on15descendants
  • K013808SleepbiteDental Imagineers, LLC · 2002 · 2 generations on11descendants
  • K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014 · 3 generations on9descendants
  • K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880956Snoar (TM) Open Airway ApplianceKent J. Toone, D.D.S.1988—
+1K971794Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc.1997—
+2K113201Narval CCResmed Sas2011—
+2K013808SleepbiteDental Imagineers, LLC2002—
+3K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc.2014—
+3K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200210
200510
200620
200910
201120
201240
201310
201420
201510
201610
201710
201810
201920
202010
202130
202210
202310
202430
202530
202620
FIG. 1 — Lineage of K880956, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (36)

See all 36

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971794Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc.199735

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, K971794 (Frantz Design, Inc., 1997) has gone furthest, with 35 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—
Cite this page

510(k) Report. “K880956: Snoar (TM) Open Airway Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K880956

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026