# K250353: Oniris; Oniris Plus

- Pathway: 510(k) (Traditional)
- Applicant: Oniris
- Decided: Sep 4, 2025 after 209 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: 7 generations back to K071404 (2007). 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)
- K200657: SmartGuard Anti-Snoring Device, Smartguard Rx, Inc. (2021) Summary page 5.

## Cited in the summary but kept off the family tree
- K1066: Oniris. Number could not be read

## Indications for use
Oniris and Oniris Plus devices are indicated for use on adult patients 18 years of age or older as an aid for the reduction of snoring (OTC). Oniris Plus device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults. (Rx)

Source page: https://510kreport.com/device/K250353
Methodology: https://510kreport.com/methodology