510(k) · Cleared
ClearedSnore Guard
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 Feb 25, 2011 as substantially equivalent to K102118 (Ranir, LLC, 2010) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 2007. 28 later devices descend from it.
- Decided
- Feb 25, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K071404 (2007). 4 ancestors in all, the oldest K882303 (1989). 28 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 1 generation backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- This deviceK103004 Snore GuardRanir, LLC · 2011
- Descendant · cites it directly · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- Descendant · 2 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
- Descendant · 3 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
- Descendant · 2 generations on · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
- Descendant · 4 generations on · 3 of its ownK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · cites it directly26descendants
- K153200SnoreRxApnea Sciences Corporation · 2016 · 2 generations on22descendants
- K170825SnoreRxApnea Sciences Corporation · 2017 · 3 generations on21descendants
- K113569ApnearxApnea Science Corporation · 2012 · 2 generations on4descendants
- K233850Difiney Anti Snoring DeviceFissiontech, LLC · 2024 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −1 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| 0 (this device) | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| +1 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| +2 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| +3 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| +2 | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
| +4 | K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K102118 | Snore Guard AdvanceSummary page 1…2010 Name of Device Snore Guard Common or Usual Name/Classification Name Intraoral Anti-Snoring Device Predicate Devices Snore Guard Advance (K102118) SleepRight Original (K1 00545) Purpose of Submission The Snore Guard is a modification to the Snore Guard Advanc… | 2010 |
| * | K100545 | SleeprightSummary page 1…uard Common or Usual Name/Classification Name Intraoral Anti-Snoring Device Predicate Devices Snore Guard Advance (K102118) SleepRight Original (K1 00545) Purpose of Submission The Snore Guard is a modification to the Snore Guard Advance. Intended Use I Indications for Use… | 2010 |
What descends from it? (28)
See all 282 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 4 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112205 (Consumer Health Products, Inc., 2011) has gone furthest, with 26 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. 2011, 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 is indicated for use in the treatment of nighttime snoring and mild to moderate
Obstructive Sleep Apnea in adults 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103004: Snore Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103004
Report an extraction error
Are you the manufacturer?
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