SleepRight Snore Aid— 510(k) K250122

Name: FDA 510(k) clearance K250122
Creator: U.S. Food and Drug Administration
Published: 2025-05-19

Substantially Equivalent

Splintek, Inc.

FDA 510(k) clearance K250122 for SleepRight Snore Aid, Substantially Equivalent on 2025-05-19. Applicant: Splintek, Inc.. Device class: 2.

Clearance details

Applicant: Splintek, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2025-01-17
Decision date: 2025-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRK

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K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)2026-08-27
K261912 — SnØreNegatØr2026-07-31
K261366 — Virtus2026-06-12
K261251 — Snorbliss® Anti-Snoring Device2026-06-11
K261134 — Dormiva Anti-Snoring Mouth Guard2026-05-14

More clearances from Splintek, Inc.

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K212767 — SleepRight Select-Comfort Dental Guard2021-12-22
K212706 — SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard2021-12-13
K193577 — SleepRight ProRx Custom Dental Guard2020-06-01
K172223 — SleepRight ProRx Custom Dental Guard2017-11-17

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.