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 Oct 2, 2020 as substantially equivalent to K183310 (Siesta Medical, Inc., 2019) after a 148-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Oct 2, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- ORY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K920213 (1992). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 7 generations between
- 3 generations backK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
- 2 generations backK133680 Encore SystemSiesta Medical, Inc. · 2014
- 1 generation backK183310 Encore SystemSiesta Medical, Inc. · 2019
- This deviceK201238 Encore SystemSiesta Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK213159 Encore SystemSiesta Medical, Inc. · 2021
Show all 11 generations
- Root · 11 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 10 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 9 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 8 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 7 generations backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- 6 generations backK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- 5 generations backK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- 4 generations backK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
- 3 generations backK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
- 2 generations backK133680 Encore SystemSiesta Medical, Inc. · 2014
- 1 generation backK183310 Encore SystemSiesta Medical, Inc. · 2019
- This deviceK201238 Encore SystemSiesta Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K213159Encore SystemSiesta Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −10 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −9 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −8 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −7 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| −6 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| −5 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
| −4 | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore… | Siesta Medical, Inc. | 2011 | — |
| −3 | K121440 | Encore Tongue Suspension System Encore Removal-Titration Kit | Siesta Medical, Inc. | 2012 | — |
| −2 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
| −1 | K183310 | Encore System | Siesta Medical, Inc. | 2019 | — |
| 0 (this device) | K201238 | Encore System | Siesta Medical, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 K213159 Encore Systemscore 5.8 · 12 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 |
|---|---|---|---|
| * | K183310 | Encore SystemSummary page 4…Y Primary Predicate Device Device Name 510(k) Number Manufacturer Siesta Medical, Inc. Encore System K183310 Reference Predicate Device Manufacturer Teleflex Medical, Inc Force Fiber Suture K063778 Device Desc… | 2019 |
| † | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213159 | Encore System | 2021 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K213159 (Siesta Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ORY devicesORY Tongue Suspension System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K201238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201238: 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/K201238
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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