Cleared Special

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 · Sleepnet Corporation · Anesthesiology
Jun 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241520 is an FDA 510(k) clearance for the 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, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on June 27, 2024, 29 days after receiving the submission on May 29, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K241520 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2024
Decision Date June 27, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

Similar Devices — CBK Ventilator, Continuous, Facility Use

All 502
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
AF531 Oro-Nasal SE Face Mask
K243394 · Respironics, Inc. · Dec 2024

More from Sleepnet Corporation

View all
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
K251847 · BZD · Jan 2026
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
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
K241469 · BZD · Jun 2024