Cleared Traditional

K190254 - Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

K190254 is an FDA 510(k) clearance for Mojo 2 Full Face Vented Mask, manufactured by Sleepnet Corporation. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K190254 · Sleepnet Corporation · Anesthesiology device
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Jul 2019
Decision
148d
Days
Class 2
Risk

K190254 is an FDA 510(k) clearance for the Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face .... 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 July 5, 2019 after a review of 148 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

FDA 510(k) Submission Details - K190254

510(k) Number K190254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2019
Decision Date July 05, 2019
Days to Decision 148 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
8d slower than avg
Panel avg: 140d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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

Sleepnet Corporation % 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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K190254.
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
K200089 · Fisher &Paykel Healthcare , Ltd. · Jun 2020
Care Orchestrator Essence
K183226 · Respironics, Inc. · Oct 2019
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
K190713 · Fisher &Paykel Healthcare , Ltd. · Oct 2019
WiZARD 310/320 Series CPAP Mask
K182394 · Apex Medical Corp. · May 2019
Moore Park Mask
K183512 · Resmed, Ltd. · May 2019
Care Orchestrator
K181053 · Respironics, Inc. · Jan 2019