# K091035: Full Breath Sleep Appliance Lower (FBSL)

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Keropian Dds
- Decided: Jun 24, 2009 after 75 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: 6 generations back to K882303 (1989). 18 ancestors in all.
7 later devices descend from it; 3 cite 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.
- K061228: Full Breath Sleep Appliance with Posterior Tongue Depressor, Bryan Keropian Dds (2006) Summary page 1.

## Most influential descendants
- 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
- K203462: Advanced Dental Appliance (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091035
Methodology: https://510kreport.com/methodology