510(k) · Cleared
ClearedEncore 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 Dec 22, 2021 as substantially equivalent to K201238 (Siesta Medical, Inc., 2020) after an 85-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Dec 22, 2021
- Review
- 85 days
- Class
- Class II
- Product code
- ORY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K920213 (1992). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 8 generations between
- 3 generations backK133680 Encore SystemSiesta Medical, Inc. · 2014
- 2 generations backK183310 Encore SystemSiesta Medical, Inc. · 2019
- 1 generation backK201238 Encore SystemSiesta Medical, Inc. · 2020
- This deviceK213159 Encore SystemSiesta Medical, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 11 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 10 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 9 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 8 generations backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- 7 generations backK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- 6 generations backK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- 5 generations backK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
- 4 generations backK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
- 3 generations backK133680 Encore SystemSiesta Medical, Inc. · 2014
- 2 generations backK183310 Encore SystemSiesta Medical, Inc. · 2019
- 1 generation backK201238 Encore SystemSiesta Medical, Inc. · 2020
- This deviceK213159 Encore SystemSiesta Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −11 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −10 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −9 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −8 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| −7 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| −6 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
| −5 | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore… | Siesta Medical, Inc. | 2011 | — |
| −4 | K121440 | Encore Tongue Suspension System Encore Removal-Titration Kit | Siesta Medical, Inc. | 2012 | — |
| −3 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
| −2 | K183310 | Encore System | Siesta Medical, Inc. | 2019 | — |
| −1 | K201238 | Encore System | Siesta Medical, Inc. | 2020 | — |
| 0 (this device) | K213159 | Encore System | Siesta Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2013 | 1 | 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
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 |
|---|---|---|---|
| * | K201238 | Encore SystemSummary page 4…edicate Device Manufacturer Device Name I SlO(k) Number Siesta Medical, Inc. Encore System I K201238 Device Description The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue… | 2020 |
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 29 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
How does its category compare?
All ORY devicesORY Tongue Suspension System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213159: Encore System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213159
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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