Cleared Traditional

K241830 - Mojo Full Face Vented Mask

Also marketed or referenced as:
Veraseal 2 Full Face Vented Mask Innova Full Face Vented Mask Ascend Full Face Vented Mask

K241830 is the FDA 510(k) clearance for Mojo Full Face Vented Mask by Sleepnet Corporation. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K241830 · Sleepnet Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
116d
Days
Class 2
Risk

K241830 is an FDA 510(k) clearance for the Mojo Full Face Vented Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on October 18, 2024 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sleepnet Corporation devices

Submission Details

510(k) Number K241830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2024
Decision Date October 18, 2024
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

ProMedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K241830.
AirFit F20 Mask System
K242547 · Resmed Pty , Ltd. · May 2025
Respiration Data Management Software (PAP Link PC)
K242935 · BMC Medical Co., Ltd. · Jan 2025
Nasal Pillow Mask - Small (NNPM-01/ Nefes S)
K243225 · Genadyne Biotechnologies, Inc. · Dec 2024
EasyCare Tx 2
K241939 · ResMed Corp · Sep 2024
myAir
K241216 · ResMed Corp · Sep 2024
AirFit F30i Mask System
K234134 · Resmed Pty Ltd (Registration Number: 3004604967) · Sep 2024