510(k) · Cleared
ClearedFull Breath Sleep Appliance Lower (FBSL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bryan Keropian Dds · LQZ Device, Jaw Repositioning
Cleared on Jun 24, 2009 as substantially equivalent to K032410 (James P Boyd, 2005) and 3 other predicates after a 75-day review. Its family tree reaches back 6 generations to 1989. 7 later devices descend from it.
- Decided
- Jun 24, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K882303 (1989). 18 ancestors in all, the oldest K880956 (1988). 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 4 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 3 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 2 generations backK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- 1 generation backK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- This deviceK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- Descendant · cites it directly · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- Descendant · 2 generations on · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · 3 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK203462 Advanced Dental ApplianceDasoft Partners · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · cites it directly6descendants
- K182312Zyppah Anti-Snoring DeviceAlways More Marketing · 2019 · 2 generations on3descendants
- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · 2 generations on1descendant
- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · 3 generations on0descendants
- K203462Advanced Dental ApplianceDasoft Partners · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −5 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −4 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −3 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −2 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| −1 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| 0 (this device) | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| +1 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +2 | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
| +2 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +3 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
| +3 | K203462 | Advanced Dental Appliance | Dasoft Partners | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 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 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 K233754 AIO Breathescore 12.9 · 11 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 |
|---|---|---|---|
| * | K032410 | SnorentiSummary page 2…reath Product Quiet Night Sleep Appl. Sleep Appl. Sleep AppL. Name Ouite Nt. MA FBAB FBPB FBPTR 510(k) K032410 K052862 K053065 K061228 Product Code LQZ LQZ LQZ… | 2005 |
| * | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite)Summary page 2…Quiet Night Sleep Appl. Sleep Appl. Sleep AppL. Name Ouite Nt. MA FBAB FBPB FBPTR 510(k) K032410 K052862 K053065 K061228 Product Code LQZ LQZ LQZ LQZ… | 2005 |
| * | K053065 | Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps)Summary page 2…Sleep Appl. Sleep Appl. Sleep AppL. Name Ouite Nt. MA FBAB FBPB FBPTR 510(k) K032410 K052862 K053065 K061228 Product Code LQZ LQZ LQZ LQZ Treatment of… | 2006 |
| * | K061228 | Full Breath Sleep Appliance with Posterior Tongue DepressorSummary page 1…Blvd., Suite 200 Tarzana, CA 91356 Product Name Full Breath Sleep Appliance Lower Proposed Product Code LQZ'. 510(k) # of device being modified K061228 Proposed Device Classification Jaw Repositioning Device Contact Person Bryan Keropian DDS tmjrelief(msn.com Te… | 2006 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K111680 (Always More Marketing, Inc., 2011) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K032410.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LQZ
1in 2024
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
MAUDE reports naming product code LQZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring.
2. Full Breath Sleep Appliance Lower - This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091035: Full Breath Sleep Appliance Lower (FBSL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091035
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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