# K183310: Encore System

- Pathway: 510(k) (Traditional)
- Applicant: Siesta Medical, Inc.
- Decided: May 9, 2019 after 161 days
- Product code: ORY (Tongue Suspension System)
- 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: 10 generations back to K920213 (1992). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133680: Encore System, Siesta Medical, Inc. (2014) Summary page 4.
- K122391: Medtronic Xomed, Inc., Medtronic Xomed, Inc. (2013) Summary page 4.

## Most influential descendants
- K201238: Encore System (2020), 1 descendant of its own
- K213159: Encore System (2021), 0 descendants of its own

## Indications for use
The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.

Source page: https://510kreport.com/device/K183310
Methodology: https://510kreport.com/methodology