510(k) Report

510(k) · Cleared

Cleared

Snorbliss® Anti-Snoring Device

K261251510(k) TraditionalCleared Jun 11, 202656-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endeavor Commerce, LLC · LRK Device, Anti-Snoring

Cleared on Jun 11, 2026 as substantially equivalent to K233850 (Fissiontech, LLC, 2024) after a 56-day review. Its family tree reaches back 7 generations to 2007.

Decided
Jun 11, 2026
Review
56 days
Class
Class II
Product code
LRK
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K071404 (2007). 12 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.

  1. Root · 7 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
  2. 6 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
  3. 5 generations backK103004 Snore GuardRanir, LLC · 2011
  4. 4 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
  5. 3 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
  6. 2 generations backK170825 SnoreRxApnea Sciences Corporation · 2017
  7. 1 generation backK233850 Difiney Anti Snoring DeviceFissiontech, LLC · 2024
  8. This deviceK261251 Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K071404Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek2007—
−6K100545SleeprightPower Products, Inc.-Splintek2010—
−5K103004Snore GuardRanir, LLC2011—
−4K112205Snorerx 9.0Consumer Health Products, Inc.2011—
−3K153200SnoreRxApnea Sciences Corporation2016—
−2K170825SnoreRxApnea Sciences Corporation2017—
−1K233850Difiney Anti Snoring DeviceFissiontech, LLC2024—
0 (this device)K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199520
199810
201010
FIG. 1 — Lineage of K261251, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K233850Difiney Anti Snoring Device
Summary page 6
…Sponsor FISSIONTECH LLC Trade/Device Name Difiney Anti Snoring Device 510(K) number K233850 Regulation Number 21 CFR 872.5570 6.Indications for use Snorbliss® Anti-Snoring Device is intended to…
Fissiontech, LLC2024—

Also cleared against K233850: 1 other device →

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 19 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
  • None of the 12 ancestors has a recall.
  • 1 other device also cites its predicate K233850.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · LRK

14in 2025

2007: 12008: 32009: 32010: 82011: 102012: 102013: 92014: 112015: 62016: 102017: 72018: 102019: 132020: 52021: 102022: 112023: 52024: 62025: 142026 (partial year): 10
2007high 14 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRK

107in 2025

2008: 109 days median2009: 88 days median2010: 195 days median2011: 134 days median2012: 142 days median2013: 233 days median2014: 219 days median2015: 117 days median2016: 157 days median2017: 170 days median2018: 200 days median2019: 150 days median2020: 80 days median2021: 126 days median2022: 154 days median2023: 156 days median2024: 254 days median2025: 107 days median2026 (partial year): 63 days median
2007high 254 (2024) · low 80 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LRK

1in 2025

2009: 22025: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LRK

653in 2025

2008: 12009: 112010: 72011: 692012: 4452013: 722014: 492015: 282016: 182017: 322018: 612019: 562020: 242021: 492022: 402023: 502024: 1852025: 653
2007high 653 (2025) · low 0 (2007)2025

MAUDE reports naming product code LRK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008310901
2009388211
2010819507
201110134069
2012101420445
20139233072
201411219049
20156117028
201610157018
20177170032
201810200061
201913150056
2020580024
202110126049
202211154040
20235156050
202462540185
2025141071653
202610631—

What is it indicated for?

Snorbliss® Anti-Snoring Device is intended to aid in the reduction of snoring.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K261251: Snorbliss® 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/K261251

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026