510(k) · Cleared
ClearedSnore Guard Advance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranir, LLC · LRK Device, Anti-Snoring
Cleared on Sep 8, 2010 as substantially equivalent to K882303 (Hays & Meade, Inc., 1989) after a 42-day review. Its family tree reaches back 1 generation to 1989. 29 later devices descend from it.
- Decided
- Sep 8, 2010
- Review
- 42 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882303 (1989). 29 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- This deviceK102118 Snore Guard AdvanceRanir, LLC · 2010
- Descendant · cites it directly · 28 of its ownK103004 Snore GuardRanir, LLC · 2011
- Descendant · 2 generations on · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- Descendant · 3 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
- Descendant · 4 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
- Descendant · 3 generations on · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K103004Snore GuardRanir, LLC · 2011 · cites it directly28descendants
- K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · 2 generations on26descendants
- K153200SnoreRxApnea Sciences Corporation · 2016 · 3 generations on22descendants
- K170825SnoreRxApnea Sciences Corporation · 2017 · 4 generations on21descendants
- K113569ApnearxApnea Science Corporation · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| 0 (this device) | K102118 | Snore Guard Advance | Ranir, LLC | 2010 | — |
| +1 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| +2 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| +3 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| +4 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| +3 | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K882303 | H&M Anti-Snoring DeviceSummary page 1…ice Snore Guard Advance Common or Usual Name/Classification Name Intraoral Anti-Snoring Device Predicate Devices Hays & Meade Anti-Snoring Device (K882303) Purpose of Submission The Snore Guard Advance is a modification to the Hays & Meade Anti-Snoring Device. Intended Use!… | 1989 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103004 | Snore Guard | 2011 | 28 |
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?
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Snore Guard Advance is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102118: Snore Guard Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102118
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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