# K150566: Oniris

- Pathway: 510(k) (Traditional)
- Applicant: Sas Oniris
- Decided: Mar 21, 2016 after 381 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: 5 generations back to K882303 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121761: Somnoguard SP Soft, Tomed Dr. Toussaint GmbH (2012) Summary page 4.

## Indications for use
The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K150566
Methodology: https://510kreport.com/methodology