510(k) · Cleared
ClearedDifiney Anti Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fissiontech, LLC · LRK Device, Anti-Snoring
Cleared on Apr 18, 2024 as substantially equivalent to K170825 (Apnea Sciences Corporation, 2017) after a 135-day review. Its family tree reaches back 6 generations to 2007. 3 later devices descend from it.
- Decided
- Apr 18, 2024
- Review
- 135 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K071404 (2007). 11 ancestors in all, the oldest K882303 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 5 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 4 generations backK103004 Snore GuardRanir, LLC · 2011
- 3 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 2 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
- 1 generation backK170825 SnoreRxApnea Sciences Corporation · 2017
- This deviceK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024
- Descendant · cites it directly · 1 of its ownK250482 Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device…Fissiontech, LLC · 2025
- Descendant · cites it directly · 0 of its ownK261251 Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253355 Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC · 2025
Most influential descendants
Showing 3 of 3 · See all- K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC · 2025 · cites it directly1descendant
- K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC · 2026 · cites it directly0descendants
- K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −5 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −4 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −3 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −2 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| −1 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| 0 (this device) | K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024 | — |
| +1 | K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC | 2025 | — |
| +1 | K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | 2026 | — |
| +2 | K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K170825 | SnoreRx Our reading of the summary gave K170285, FDA’s number for AED Sinuscope (National Advanced Endoscopy Devices, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SnoreRx”. | 2017 |
What descends from it? (3)
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?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K250482 (Fissiontech, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K170825.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233850: Difiney Anti Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233850
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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