# K213159: Encore System

- Pathway: 510(k) (Traditional)
- Applicant: Siesta Medical, Inc.
- Decided: Dec 22, 2021 after 85 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: 12 generations back to K920213 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201238: Encore System, Siesta Medical, Inc. (2020) Summary page 4.

## 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/K213159
Methodology: https://510kreport.com/methodology