510(k) · Cleared
ClearedEncore Tongue Suspension System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siesta Medical, Inc. · ORY Tongue Suspension System
Cleared on Nov 7, 2012 as substantially equivalent to K111179 (Siesta Medical, Inc., 2011) after a 140-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Nov 7, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- ORY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K920213 (1992). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 7 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 6 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 5 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 4 generations backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- 3 generations backK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- 2 generations backK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- 1 generation backK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
- This deviceK121814 Encore Tongue Suspension SystemSiesta Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −7 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −6 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −5 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −4 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| −3 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| −2 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
| −1 | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore… | Siesta Medical, Inc. | 2011 | — |
| 0 (this device) | K121814 | Encore Tongue Suspension System | Siesta Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ORY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ORY device
- #1 K201238 Encore Systemscore 6.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K111179.
How does its category compare?
All ORY devicesORY Tongue Suspension System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ORY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · ORY
Too few ORY 510(k)s in any year since 2007 to give a median.
Recalls per year · ORY
No recall names ORY since 2007.
Adverse event reports per year · ORY
5in 2025
MAUDE reports naming product code ORY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Siesta Medical Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121814: Encore Tongue Suspension System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121814
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026