510(k) · Cleared
ClearedFull Breath Sleep Appliance with Posterior Tongue Depressor
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 May 26, 2006 as substantially equivalent to K032410 (James P Boyd, 2005) and 6 other predicates after a 24-day review. Its family tree reaches back 5 generations to 1989. 8 later devices descend from it.
- Decided
- May 26, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K882303 (1989). 17 ancestors in all, the oldest K880956 (1988). 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 3 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 2 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 1 generation backK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- This deviceK061228 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
- Descendant · 4 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −3 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −2 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −1 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| 0 (this device) | 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 | — |
| +4 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
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 |
|---|---|---|
| 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? (7)
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…atment of mild and moderate OSA, the Full Breath Sleep Appliance With Posterior Tongue Restrainer is substantially equivalent (SE) to the Quiet Night & Quiet Night MA (K0324 10), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior… | 2005 |
| * | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite)Summary page 2…Tongue Restrainer is substantially equivalent (SE) to the Quiet Night & Quiet Night MA (K0324 10), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065) For the treatment of snoring, the Full Br… | 2005 |
| * | K053065 | Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps)Summary page 2…(K0324 10), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065) For the treatment of snoring, the Full Breath Appliance With Posterior Tongue Restrainer is SE to the Quiet Night & Quiet Night… | 2006 |
| * | K022891 | The Breathe EZ Anti-Snoring DeviceSummary page 2…Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065), the Breathe EZ Anti-Snoring Device (K022891), the SleepBite (K103808), and Dr. B's Mouthpiece (K991948). For the treatment of bruxism, the Full Breath Sleep Appliance is SE… | 2003 |
| * | K013808 | Sleepbite Our reading of the summary gave K103808, FDA’s number for Sapphire NC (Orbusneich Medical, Inc.), decided Sep 1, 2011, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SleepBite”. | 2002 |
| * | K991948 | DR. B'S Mouthpiece, Model 32129-10002Summary page 2…ll Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065), the Breathe EZ Anti-Snoring Device (K022891), the SleepBite (K103808), and Dr. B's Mouthpiece (K991948). For the treatment of bruxism, the Full Breath Sleep Appliance is SE to the NTI Tension Supression System (KO10876), the Breath… | 1999 |
| * | K010876 | Nti Tension Suppression SystemSummary page 2…. B's Name FBAB&FBPB Quiet Nt. MA System Device Mouthpiece K052862 510(k) K053065 K032410 K010876 K022891 K 103808 K991948 Product Code LOZ LOZ LOZ LRK… | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091035 | Full Breath Sleep Appliance Lower (FBSL) | 2009 | 7 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K091035 (Bryan Keropian Dds, 2009) has gone furthest, with 7 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.
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 With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring.
2. Full Breath Sleep-Appliance With Posterior Tongue Depressor - 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/K061228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061228: Full Breath Sleep Appliance with Posterior Tongue Depressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061228
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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