510(k) · Cleared
ClearedFull Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps)
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 Jan 3, 2006 as substantially equivalent to K032410 (James P Boyd, 2005) after a 63-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.
- Decided
- Jan 3, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032410 (2005). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032410 SnorentiJames P Boyd · 2005
- This deviceK053065 Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior…Bryan Keropian Dds · 2006
- Descendant · cites it directly · 8 of its ownK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- Descendant · cites it directly · 7 of its ownK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- Descendant · 2 generations on · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- Descendant · 3 generations on · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K182312Zyppah Anti-Snoring DeviceAlways More Marketing · 2019 · 3 generations on3descendants
- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032410 | Snorenti | James P Boyd | 2005 | — |
| 0 (this device) | K053065 | Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with… | Bryan Keropian Dds | 2006 | — |
| +1 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| +1 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| +2 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +3 | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
| +3 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (1)
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…18 510(K) Summary (continued) This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination… | 2005 |
| † | K022891 | The Breathe EZ Anti-Snoring Device | 2003 |
| † | K103808 | Sapphire NC | 2011 |
| † | K954530 | The Silencer | 1995 |
What descends from it? (9)
2 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?
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
For the treatment of snoring.
For the prevention of bruxism.
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/K053065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053065: Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053065
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