510(k) · Cleared
ClearedElevo® Kit Snoring Intervention Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zelegent, Inc. · LRK Device, Anti-Snoring
Cleared on Dec 6, 2018 as substantially equivalent to K110623 (Medtronic Xomed, Inc., 2012) after a 224-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Dec 6, 2018
- Review
- 224 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K920213 (1992). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK920213 Mitek Anchor, Mitek Anchor IIMitek Surgical Products, Inc. · 1992
- 6 generations backK962372 Urotac Bone Anchor InserterInfluence, Inc. · 1996
- 5 generations backK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
- 4 generations backK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
- 3 generations backK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- 2 generations backK011723 Anti-Snoring Device or AsdPi Medical · 2002
- 1 generation backK110623 Pillar Palatal Implant SystemMedtronic Xomed, Inc. · 2012
- This deviceK181107 Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213475 Elevo Snoring Intervention SetZelegent, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213475Elevo Snoring Intervention SetZelegent, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920213 | Mitek Anchor, Mitek Anchor II | Mitek Surgical Products, Inc. | 1992 | — |
| −6 | K962372 | Urotac Bone Anchor Inserter | Influence, Inc. | 1996 | — |
| −5 | K970292 | IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw | Influence, Inc. | 1997 | 1 |
| −4 | K972023 | Sleep-in Bone Screw System | Influence, Inc. | 1997 | — |
| −3 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| −2 | K011723 | Anti-Snoring Device or Asd | Pi Medical | 2002 | — |
| −1 | K110623 | Pillar Palatal Implant System | Medtronic Xomed, Inc. | 2012 | — |
| 0 (this device) | K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | 2018 | — |
| +1 | K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K110623 | Pillar Palatal Implant SystemSummary page 4…Pillar™ Palatal Implant System Manufactured by Medtronic XOMED, Inc. PREDICATE DEVICE 510(k): K110623 REFERENCE DEVICE: Quill™ Absorbable Suture Manufacture… | 2012 |
| † | K132268 | Quill Pdo Knotless Tissue-Closure Device, Variable Loop Design | 2013 |
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 |
|---|---|---|---|
| K213475 | Elevo Snoring Intervention Set | 2022 | 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 26 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K213475 (Zelegent, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181107: Elevo® Kit Snoring Intervention Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181107
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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