# K133680: Encore System

- Pathway: 510(k) (Traditional)
- Applicant: Siesta Medical, Inc.
- Decided: Mar 26, 2014 after 114 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: 9 generations back to K920213 (1992). 17 ancestors in all.
3 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)
- K121440: Encore Tongue Suspension System Encore Removal-Titration Kit, Siesta Medical, Inc. (2012) Summary page 1.
- K122391: Medtronic Xomed, Inc., Medtronic Xomed, Inc. (2013) Summary page 1.

## Most influential descendants
- K183310: Encore System (2019), 2 descendants of its own
- 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 to be used for anterior advancement of the tongue base. It is also suitable for performing hyoid suspension. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and for snoring.

Source page: https://510kreport.com/device/K133680
Methodology: https://510kreport.com/methodology