# K130797: Luco Hybrid Osa Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Luco Hybrid Osa Appliance, Inc.
- Decided: Dec 18, 2013 after 271 days
- Product code: LRK (Device, Anti-Snoring)
- 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: 9 generations back to K882303 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.
- K121285: Oravan Osa, New Jersey Snoring Solutions (2013) Summary page 1.
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013). Cleared while this submission was under review Summary page 1.

## Indications for use
This appliance is designed to treat primary snoring and mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K130797
Methodology: https://510kreport.com/methodology