510(k) · Cleared
ClearedSnore-Aid Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Imagineers, LLC · LRK Device, Anti-Snoring
Cleared on Jul 22, 1999 as substantially equivalent to K955336 (Scott Feldman Dds & Norman Shapiro Dds, 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Jul 22, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882303 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K022284Snore-Aid MaxDental Imagineers, LLC · 2002 · cites it directly0descendants
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) | K991449 | Snore-Aid Plus | Dental Imagineers, LLC | 1999 | — |
| +1 | K022284 | Snore-Aid Max | Dental Imagineers, LLC | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K955336 | SnorefreeSummary page 1…name: Anti-Snoring Device Classification name: Device, Anti-Snoring Substantial Equivalence Device: The Snore-Aid®p/ius is substantially equivalent to the Snore Free® K955336 (also known as the Rest Assured® appliance) and the Snore Guard® K882303 appliances. Description of Device: Snore-Aid®plus is a… | 1996 |
| * | K882303 | H&M Anti-Snoring DeviceSummary page 1…bstantial Equivalence Device: The Snore-Aid®p/ius is substantially equivalent to the Snore Free® K955336 (also known as the Rest Assured® appliance) and the Snore Guard® K882303 appliances. Description of Device: Snore-Aid®plus is a single plate mandibular advancement and tongue positioning orthotic consi… | 1989 |
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 |
|---|---|---|---|
| K022284 | Snore-Aid Max | 2002 | 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?
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?
Snore-Aid®plus is prescribed for the patient by the healthcare professional.
A. Snore-Aid®plus is indicated for use in patients with primary snoring or snoring and mild obstructive sleep apnea (OSA) where mandibular-advancement and positioning of the tongue can increase pharyngeal air space.
B. Snore-Aid®plus is indicated to prevent symptoms of nocturnal parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991449: Snore-Aid Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991449
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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