510(k) Report

510(k) · Cleared

Cleared

OSAP

K960673510(k) TraditionalCleared May 9, 199679-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

Snorefree, Inc. · LQZ Device, Jaw Repositioning

Cleared on May 9, 1996 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 102 later devices descend from it.

Decided
May 9, 1996
Review
79 days
Class
Class II
Product code
LQZ
Recalls
None
Predicates
0

102 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2012: 9 descendants cleared2018: 5 descendants cleared2016: 7 descendants cleared2023: 5 descendants cleared2005: 2 descendants cleared1998: 1 descendant cleared2003: 2 descendants cleared2006: 6 descendants cleared2017: 5 descendants cleared2011: 6 descendants cleared2008: 1 descendant cleared2021: 6 descendants cleared2014: 5 descendants cleared2009: 4 descendants cleared2025: 6 descendants cleared2010: 2 descendants cleared2013: 5 descendants cleared2019: 4 descendants cleared2015: 3 descendants cleared2026: 4 descendants cleared2020: 6 descendants cleared2022: 3 descendants cleared2024: 3 descendants cleared1995200020052010201520202025
  1. This deviceK960673 OSAPSnorefree, Inc. · 1996
  2. Descendant · cites it directly · 95 of its ownK972061 TOAW. Keith Thornton, D.D.S. · 1997
  3. Descendant · 2 generations on · 75 of its ownK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
  4. Descendant · 2 generations on · 65 of its ownK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
  5. Descendant · 2 generations on · 51 of its ownK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
  6. Descendant · 2 generations on · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12003: 22005: 22006: 62008: 12009: 42010: 22011: 62012: 92013: 52014: 52015: 32016: 72017: 52018: 52019: 42020: 62021: 62022: 32023: 52024: 32025: 62026: 4
1997high 9 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 102 · See all
  • K972061TOAW. Keith Thornton, D.D.S. · 1997 · cites it directly95descendants
  • K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003 · 2 generations on75descendants
  • K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003 · 2 generations on65descendants
  • K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 2006 · 2 generations on51descendants
  • K061732TAP-TAirway Management, Inc. · 2006 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960673OSAPSnorefree, Inc.1996—
+1K972061TOAW. Keith Thornton, D.D.S.1997—
+2K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage2003—
+2K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc.2003—
+2K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc.2006—
+2K061732TAP-TAirway Management, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200320
200520
200660
200810
200940
201020
201160
201290
201350
201450
201530
201670
201750
201850
201940
202060
202160
202230
202350
202430
202560
202640
FIG. 1 — Lineage of K960673, 1996–2026Source: 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (102)

See all 102

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

NumberDeviceApplicantDecidedDescendants
K972061TOAW. Keith Thornton, D.D.S.199795
K113569ApnearxApnea Science Corporation20124
K964516TAPNellcor Puritan Bennett, Inc.19970

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, K972061 (W. Keith Thornton, D.D.S., 1997) has gone furthest, with 95 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. “K960673: OSAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960673

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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