# K061228: Full Breath Sleep Appliance with Posterior Tongue Depressor

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Keropian Dds
- Decided: May 26, 2006 after 24 days
- Product code: LQZ (Device, Jaw Repositioning)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K882303 (1989). 17 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032410: Snorenti, James P Boyd (2005) Summary page 2.
- K052862: Full Breath Sleep Appliance - AB (Anterior Bite), Bryan Keropian Dds (2005) Summary page 2.
- K053065: Full Breath Sleep Appliance - PB (Posterior Bite and PBB (Posterior Bite with Bumps), Bryan Keropian Dds (2006) Summary page 2.
- K022891: The Breathe EZ Anti-Snoring Device, D&S Redhage (2003) Summary page 2.
- K013808: Sleepbite, Dental Imagineers, LLC (2002). 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”.
- K991948: DR. B'S Mouthpiece, Model 32129-10002, Snore - Ezzer (1999) Summary page 2.
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001) Summary page 2.

## Most influential descendants
- K091035: Full Breath Sleep Appliance Lower (FBSL) (2009), 7 descendants of its own
- K111680: DR. Greensburg's Hybrid (2011), 6 descendants of its own
- K182312: Zyppah Anti-Snoring Device (2019), 3 descendants of its own
- K252531: Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (2026), 1 descendant of its own
- K261912: SnØreNegatØr (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061228
Methodology: https://510kreport.com/methodology