Cleared Abbreviated

AIO Breathe

K252525 · Aiomega, LLC · Dental

Nov 2025

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K252525 is an FDA 510(k) clearance for the AIO Breathe, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Aiomega, LLC (Tyler, US). The FDA issued a Cleared decision on November 6, 2025, 87 days after receiving the submission on August 11, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K252525 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2025
Decision Date	November 06, 2025
Days to Decision	87 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF