510(k) · Cleared
ClearedAnti-Snoring Device or Asd
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pi Medical · LRK Device, Anti-Snoring
Cleared on Dec 18, 2002 as substantially equivalent to K981677 (Influence, Inc., 1999) and 1 other predicate after a 562-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Dec 18, 2002
- Review
- 562 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K920213 (1992). 12 ancestors in all. 4 later devices descend from it, 2 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 backK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
- This deviceK011723 Anti-Snoring Device or AsdPi Medical · 2002
- Descendant · cites it directly · 2 of its ownK110623 Pillar Palatal Implant SystemMedtronic Xomed, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK181107 Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK213475 Elevo Snoring Intervention SetZelegent, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK040417 Pillar Palatal Implant SystemRestore Medical, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K110623Pillar Palatal Implant SystemMedtronic Xomed, Inc. · 2012 · cites it directly2descendants
- K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 2018 · 2 generations on1descendant
- K213475Elevo Snoring Intervention SetZelegent, Inc. · 2022 · 3 generations on0descendants
- K040417Pillar Palatal Implant SystemRestore Medical, Inc. · 2004 · cites it directly0descendants
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 | K981677 | Repose Bone Screw System | Influence, Inc. | 1999 | 2 |
| 0 (this device) | K011723 | Anti-Snoring Device or Asd | Pi Medical | 2002 | — |
| +1 | K110623 | Pillar Palatal Implant System | Medtronic Xomed, Inc. | 2012 | — |
| +2 | K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | 2018 | — |
| +3 | K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | 2022 | — |
| +1 | K040417 | Pillar Palatal Implant System | Restore Medical, Inc. | 2004 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K981677 | Repose Bone Screw SystemSummary page 2…exceeded all performance requirements. CONCLUSION: The Pi Medical Anti-Snoring Device is substantially equivalent to the Repose Bone Screw System (K981677) in its pmducl code, intended use, design, materials and irs use of a permanent implant to addres… | 1999 |
| * | K971450 | Somnoplasty SystemSummary page 2…ermanent implant to address snoring problems. In addition, the Anti-Snoring Device is substantially equivalent to thc Somnoplasty System (K97 1450) in its intended use, target population, design, function, and approach to snoring management. Te… | 1997 |
What descends from it? (4)
2 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 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K110623 (Medtronic Xomed, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K981677.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Anti-Snoring 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/K011723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011723: Anti-Snoring Device or Asd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011723
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026