510(k) · Cleared
ClearedSnore-Aid Max
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 Dec 10, 2002 as substantially equivalent to K991449 (Dental Imagineers, LLC, 1999) and 2 other predicates after a 148-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Dec 10, 2002
- Review
- 148 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K882303 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −1 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| 0 (this device) | K022284 | Snore-Aid Max | Dental Imagineers, LLC | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K991449 | Snore-Aid PlusSummary page 1…: Device, Anti-snoring Substantial Equivalence Devices: The Snore-Aid@ Max appliance is substantially equivalent to its predicate Snore-Aid@ Plus device ( K 991449), Quiet Knight (K9625 16), and Snore Guard 6 8 8 2 3 0 3 ) devices. Snore-Aid03 Plus js a single plate mandibular advancement an… | 1999 |
| * | K962516 | Tap Anti-Snoring DeviceSummary page 1…nti-snoring Substantial Equivalence Devices: The Snore-Aid@ Max appliance is substantially equivalent to its predicate Snore-Aid@ Plus device ( K 991449), Quiet Knight (K9625 16), and Snore Guard 6 8 8 2 3 0 3 ) devices. Snore-Aid03 Plus js a single plate mandibular advancement and tongue positioning orth… | 1996 |
| * | K882303 | H&M Anti-Snoring Device | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 5 ancestors has a recall.
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 Max is prescribed for the patient by the healthcare professional
Snore-Aid Max is indicated for use in patients with benign snoring or snoring and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space
Snore-Aid Max is indicated to prevent symptoms of nocturnal parafunctional jaw activity in patients who are undergoing treatment for snoring and/or OSA by mandibular advancement and tongue positioning
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022284: Snore-Aid Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022284
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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