510(k) · Cleared
ClearedPrelude Iii 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 Apr 8, 2011 as substantially equivalent to K103179 (Siesta Medical, Inc., 2010) after an 80-day review. Its family tree reaches back 6 generations to 1992. 13 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- ORY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K920213 (1992). 12 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 5 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 4 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 3 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 2 generations backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- 1 generation backK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- This deviceK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK133680 Encore SystemSiesta Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc. · 2011 · cites it directly6descendants
- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · cites it directly5descendants
- K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012 · 2 generations on4descendants
- K133680Encore SystemSiesta Medical, Inc. · 2014 · 3 generations on3descendants
- K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −5 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −4 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −3 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −2 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| −1 | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| 0 (this device) | 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 | — |
| +1 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| +2 | K121440 | Encore Tongue Suspension System Encore Removal-Titration Kit | Siesta Medical, Inc. | 2012 | — |
| +3 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
| +2 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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
- #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 |
|---|---|---|---|
| * | K103179 | Prelude II Tounge Suspension SystemSummary page 1…te Device Manufacturer Device Name 510(k) Number Siesta Medical, Inc. PRELUDE 11 Tongue K103 179 Suspension System Description The PRELUDE IIl Tongue Suspension System is designed for ant… | 2010 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K111179 (Siesta Medical, Inc., 2011) has gone furthest, with 6 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. 2011, 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. PRELUDE III 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/K110127 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110127: Prelude Iii Tongue Suspension System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110127
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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