510(k) · Cleared
ClearedPrelude II Tounge 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 Dec 20, 2010 as substantially equivalent to K101060 (Siesta Medical, Inc., 2010) after a 53-day review. Its family tree reaches back 5 generations to 1992. 14 later devices descend from it.
- Decided
- Dec 20, 2010
- Review
- 53 days
- Class
- Class II
- Product code
- ORY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K920213 (1992). 11 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 4 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 3 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 2 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 1 generation backK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
- This deviceK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010
- Descendant · cites it directly · 13 of its ownK110127 Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK111179 Encore Tongue Suspension System (Monofilament #1 Suspension Suture)…Siesta Medical, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK121440 Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012
- Descendant · 4 generations on · 3 of its ownK133680 Encore SystemSiesta Medical, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc. · 2011 · cites it directly13descendants
- K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc. · 2011 · 2 generations on6descendants
- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 2 generations on5descendants
- K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc. · 2012 · 3 generations on4descendants
- K133680Encore SystemSiesta Medical, Inc. · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −4 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −3 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −2 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −1 | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension System | Siesta Medical, Inc. | 2010 | — |
| 0 (this device) | K103179 | Prelude II Tounge Suspension System | Siesta Medical, Inc. | 2010 | — |
| +1 | K110127 | Prelude Iii Tongue Suspension System | Siesta Medical, Inc. | 2011 | — |
| +2 | K111179 | Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore… | Siesta Medical, Inc. | 2011 | — |
| +2 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| +3 | K121440 | Encore Tongue Suspension System Encore Removal-Titration Kit | Siesta Medical, Inc. | 2012 | — |
| +4 | K133680 | Encore System | Siesta Medical, Inc. | 2014 | — |
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 | 2 | 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 |
|---|---|---|---|
| * | K101060 | Siesta Medical, Inc., Prelude Tongue Suspension SystemSummary page 1…__________ Manufacturer Device Name I10(k) Number Siesta Medical, Inc. PRELUDE Tongue K10 1060 Suspension System Description The PRELUDE 11 Tongue Suspension System is designed for anter… | 2010 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110127 | Prelude Iii Tongue Suspension System | 2011 | 13 |
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 18 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K110127 (Siesta Medical, Inc., 2011) has gone furthest, with 13 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. 2010, 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 11 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 for snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103179: Prelude II Tounge 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/K103179
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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