# K261366: Virtus

- Pathway: 510(k) (Special)
- Applicant: Somnomed, Inc.
- Decided: Jun 12, 2026 after 46 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: 6 generations back to K882303 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183443: SomnoDent Avant, Somnomed, Inc. (2019) Summary page 5.

## Indications for use
Virtus is a patient-matched mandibular advancement device (MAD), available under medical prescription and intended for the treatment in patients 18 years of age or older with: » Mild to moderate obstructive sleep apnea (OSA) » Snoring

Source page: https://510kreport.com/device/K261366
Methodology: https://510kreport.com/methodology