510(k) · Cleared
ClearedSnoring Control Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenneth Hilsen · LRK Device, Anti-Snoring
Cleared on Jan 9, 1998 after a 487-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.
- Decided
- Jan 9, 1998
- Review
- 487 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK963591 Snoring Control DeviceKenneth Hilsen · 1998
- 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 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K963591 | Snoring Control Device | Kenneth Hilsen | 1998 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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 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? (30)
See all 302 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, 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.
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 Anti-Snoring Device is intended to alleviate or correct snoring.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963591: Snoring Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963591
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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