# K160477: The Luco Hybrid OSA Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Luco Hybrid Osa Appliance, Inc.
- Decided: Jul 29, 2016 after 161 days
- Product code: OCO (Mouthguard, Migraine/Tension Headache)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240463: Slow Wave DS8 (SWDS802) (2024), 0 descendants of its own

## Indications for use
1. A device to be used for the treatment of sleep bruxism and 2. As an aid in the treatment of associated tension/migraine type headaches in adults.

Source page: https://510kreport.com/device/K160477
Methodology: https://510kreport.com/methodology