Cleared Traditional

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

K251847 · Sleepnet Corporation · Anesthesiology
Jan 2026
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K251847 is an FDA 510(k) clearance for the Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on January 15, 2026, 213 days after receiving the submission on June 16, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K251847 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date January 15, 2026
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

More from Sleepnet Corporation

View all
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
K241830 · BZD · Oct 2024
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
K241943 · CBK · Aug 2024
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
K241661 · BZD · Jul 2024
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
K241520 · CBK · Jun 2024
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
K241469 · BZD · Jun 2024