510(k) · Cleared
ClearedSnorefree
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scott Feldman Dds & Norman Shapiro Dds · LRK Device, Anti-Snoring
Cleared on Jan 4, 1996 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jan 4, 1996
- Review
- 45 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK955336 SnorefreeScott Feldman Dds & Norman Shapiro Dds · 1996
- Descendant · cites it directly · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
- Descendant · 2 generations on · 1 of its ownK223901 ApneaRX ProApnea Sciences Coporation · 2023
- Descendant · cites it directly · 1 of its ownK991449 Snore-Aid PlusDental Imagineers, LLC · 1999
- Descendant · 3 generations on · 0 of its ownK250122 SleepRight Snore AidSplintek, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK181396 Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113569ApnearxApnea Science Corporation · 2012 · cites it directly4descendants
- K223901ApneaRX ProApnea Sciences Coporation · 2023 · 2 generations on1descendant
- K991449Snore-Aid PlusDental Imagineers, LLC · 1999 · cites it directly1descendant
- K250122SleepRight Snore AidSplintek, Inc. · 2025 · 3 generations on0descendants
- K181396Oral Device OA, Oral Device SPassion For Life Healthcare (Uk) Limited · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955336 | Snorefree | Scott Feldman Dds & Norman Shapiro Dds | 1996 | — |
| +1 | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
| +2 | K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023 | — |
| +1 | K991449 | Snore-Aid Plus | Dental Imagineers, LLC | 1999 | — |
| +3 | K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025 | — |
| +2 | K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
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?
- Of its descendants, K113569 (Apnea Science Corporation, 2012) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K955336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955336: Snorefree.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955336
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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