# K213475: Elevo Snoring Intervention Set

- Pathway: 510(k) (Traditional)
- Applicant: Zelegent, Inc.
- Decided: Jan 27, 2022 after 90 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: 8 generations back to K920213 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181107: Elevo® Kit Snoring Intervention Device, Zelegent, Inc. (2018) Summary page 4.

## Indications for use
The Elevo Snoring Intervention Set is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.

Source page: https://510kreport.com/device/K213475
Methodology: https://510kreport.com/methodology